ASQ Los Angeles Chapter
EMPLOYMENT LISTINGS
Date: April 17, 2008
Job Title: Software Quality Assurance Manager
Location: Los Angeles
Organization: Client is a leader in the entertainment sector who has successfully pioneered new technologies for internal reporting and improved customer satisfaction.
Responsibilities:
· Report to the Director of Software Quality Assurance.
· Manage a team of software test analysts, responsible for planning and executing testing phases of multiple CRM systems.
Requirements:
· Five to ten years in software quality assurance in a time-to-market-driven environment.
· At least five years experience in line or project management of a team of SQA Analysts responsible for planning and executing test phases of multiple CRM systems.
· Experience in SDLC metrologies required (for evaluating the testability of requirements and estimating testing timelines).
· Prior exposure to Mercury test automation tools is desirable.
· Experience in all stages of software quality assurance testing including functional, integration, performance, and operational testing.
· Expertise in risk management techniques.
· Experience in SQL to identify test data and validate results.
· Experience with Order Management systems applications.
· Experience in DBS, Cable and/or Consumer Electronics industries.
· SQA development or systems engineering experience in Enterprise Integration Architecture and/or .com.
· Minimum of three years of testing Siebel applications.
Respond to: Sharon Syfrett
Stuart Morris & Associates Inc.
24931 Largo
Laguna Hills, CA 92653
stumor@cox.net
Fax: 949 837 6196
Phone: 949 837 0343
Date: April 16, 2008
Job Title: Quality Engineer
Location: Torrance
Organization: Sakura Finetek.
Responsibilities:
· Prepares quality plans, procedures and instructions in accordance with QA policies and stated requirements of specific program contract specifications.
· Participates in design/process reviews, evaluates the need for possible inspection tooling and/or test equipment.
· Reviews manufacturing and assembly planning for appropriate sequenced quality requirements. Prepares appropriate check lists for quality control points throughout the manufacturing/assembly processes.
· Act as direct quality liaison with Engineering, Manufacturing, Assembly, Procurement, suppliers and customers.
· Performs investigative research with discrepant materials and quality processes; compiles information, analyzes issues related to the root causes and initiates corrective action. Monitors and reports progress on failure analyses, corrective and preventive actions.
· Develops improvements in, or designs new work methods and procedures for testing and inspecting the quality level of products and production equipment.
· Initiates appropriate identification of quality problems and identification and implementation of corrective action required.
· Monitors and verifies the completion and effectiveness of corrective actions committed to customers or resulting from internal deficiencies.
· Develops, performs and reports quality auditing activities.
· Performs material review and disposition of discrepant items discovered at all stages of production. Participates on corrective action board, failure review board and continuous improvement committee.
Requirements:
· B.S. in Mechanical, Industrial or Electrical Engineering or equivalent combination of education and experience.
· Three to five years experience in manufacturing environment with a minimum of three years as Quality Engineer.
· ASQ certification as Quality Engineer or Six Sigma Black Belt desired.
· Must be familiar with ISO 9001 and ISO 13485 requirements.
· Medical device manufacturing experience preferred
Respond to: Betty McDonald
AA/EOE/M/F/D/V
Sakura Finetek USA, Inc.
1750 W. 214th Street
Torrance, CA 90501
bmcdonald@sakuraus.com
Date: April 16, 2008
Job Title: Quality Assurance Supervisor
Location: Los Angeles
Salary: $68-75K
Organization:
Responsibilities:
· Assist the Director of QA in all matters related to quality, compliance, governmental and operational activities. These would include NIOSH, FDA, State DHS, ISO, and Australia SAI Global.
· Work with purchasing staff to establish quality requirements from external suppliers.
· Identify and implement relevant quality-related training needs.
· Supervise technical staff in carrying out test and checks.
· Develop effective test strategies and test plan for existing and new products.
· Plan, schedule and implement testing projects.
· Provide quality and regulatory requirements for modified and new products.
· Research and identify process improvements and help set standards and define best practice for testing.
· Perform statistical analysis on processes and make recommendations for improvements as appropriate.
· Maintain the corrective/preventive action program.
· Assist in preparing governmental submission to agencies such as NIOSH and FDA 510(k)s.
· Provide input into new product design and development.
· Coordinate and manage the Internal Audit program and provide documented reports.
· Work with production personnel in an advisory role to assist them with quality issues within their department and provide quality training.
· Troubleshoot and resolve product quality problems by researching problems, analyzing data, and developing solutions to problems.
Requirements:
· Bachelors in Engineering or Science.
· Knowledge of regulatory requirements such as FDA.
· Experience in manufacturing and/or quality related field
Respond to: Mike Davis
mdavis@purcellintl.com
Date: April 8, 2008
Job Title: Quality Engineer
Location: Long Beach
Salary: $60 - $65K
Organization: ISO9000 certified global manufacturer of printed consumer products.
Responsibilities:
Assist QA Manager in bringing lean and six sigma techniques to the floor.
Requirements:
· Minimum of an Associates Degree in Engineering, Bachelor’s Degree preferred with at least two years experience in a quality engineering role within a high volume manufacturing environment.
· Knowledge of 5S, Kaizen and/or other lean manufacturing principles is required.
· Six Sigma Green Belt a plus.
Respond to: Dani Schade
dschade@midlandconsultants.com
or fax: Dani Schade/Midland Consultants at 440-234-1758
Interested applicants should submit their resume via email or fax. Microsoft Word preferred.
Date: April 8, 2008
Job Title: Director, CMC Regulatory Affairs & Quality Systems
Location: San Diego
Organization: Ambrx, Inc., a biopharmaceutical company with a mission to deliver breakthrough protein therapeutics. EOE.
Responsibilities:
· Develop and implement global CMC regulatory strategies.
· Identify and assess regulatory risks associated with product development, and develop and implement strategies to minimize risks.
· Develop, implement and maintain compliance with quality systems and processes.
· Perform periodic cGMP and cGLP audits of, and assist in the qualification and ongoing management of, suppliers and contract manufacturing and research organizations.
· Prepare clear, accurate and effective regulatory submissions.
· Represent the Company in interactions with regulatory authorities, contractors and corporate partners.
· Monitor and analyze appropriate regulatory authority activities in areas of interest.
· In close coordination with the Company’s clinical development leadership, provide guidance and assist in the development of the Company’s overall global regulatory strategies.
Requirements:
· Bachelors, masters or PhD degree in a scientific discipline and minimum of seven (7) years experience in a regulatory drug development environment.
· Demonstrated record of preparing and prosecuting major regulatory submissions.
· Strong knowledge of regulatory requirements in the US (FDA) and Europe (EMEA).
· Experience in assessing compliance of CMC documents with applicable regulatory guidelines and regulations relevant to manufacturing, pre-clinical, and clinical development of protein-based therapeutics.
· Experience in assessing impact of proposed CMC, clinical protocol and other changes to licenses and clinical trial applications.
· Experience in interfacing successfully with regulatory authorities in the US and EU.
· Ability to travel extensively as required to perform cGMP and cGLP audits.
Respond to: Alda Jorgenson, Recruiting Consultant for Ambrx, Inc
Date: April 4, 2008
Job Title: Director of Quality Assurance
Location: Orange County
Organization: A well recognized and highly regarded aerospace company that specializes in the design and manufacturing of safety-related products for military and aerospace applications
Responsibilities:
· Restructured leadership position is needed to develop, maintain and strengthen all quality systems and ensure quality compliance by the entire organization based in Southern California.
· Rapidly assess the current status of the company’s quality assurance processes. At the completion of initial review, review findings with senior management and recommend an action plan.
· Proactively build and manage a high performing team. This includes assessing the current personnel, reorganizing if necessary and oversight of team to ensure performance.
· Implement change processes to transform the Quality Assurance culture from relying on in-process inspection to a culture that is proactive with quality processes designed into production.
· Elevate the company’s focus on quality, including achieving greater production efficiencies while ensuring the accuracy and integrity of the work.
· Achieve AS9100 certification at one facility and retain ISO 9001 certification at another.
· Develop a supplier Quality plan that ensures all requirements are properly flowed down to the suppliers.
· Direct and indirect involvement with customers throughout projects in the review of contracts and customer requirements, etc.
· Ensure that QA is implemented early in design and production planning to anticipate quality assurance issues in production processes.
· Implement a quality metrics program.
Requirements:
· Background in aerospace product quality assurance.
· Bachelor Degree required, preferably in Engineering or Physical Science. MS Degree is a plus.
· 10 to 15 years of aerospace product quality assurance experience, with five to eight years of overall quality management experience.
· Experience with engineered safety-related products for military and aerospace applications desirable.
· Experience with and oriented toward metrics in business analysis.
· Experience with having obtained an ISO 9001 and AS9100 certification desired.
Respond to: Kaitlyn Nash
kaitlyn@bobsearch.com
Date: April 3, 2008
Job Title: Sr. Quality Engineer
Location: Colorado Springs, CO
Organization: Spectranetics
Responsibilities:
· Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet requirements established by Spectranetics, customers and regulatory agencies.
· Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives.
· Provides focused quality engineering support within new product development.
· Maintains Risk Management documentation and provides Quality Engineering support for the life cycle of all Spectranetics products.
· Provide QA leadership to project and system for the fill lifecycle of the product, service or system.
· Develops, updates and maintains SOPs, forms, methods related to Quality in the NPI/DC SOP and Risk Management system.
· Ensures Risk Management is effective utilizing feedback from validation, field safety, manufacturing indicators, CAPAs, HHAs, etc.
· Leads and supports Health Hazard Analysis to ensure risk assessment and root cause analysis across products and systems.
Requirements: Not stated.
Respond to: Julianne Mashke
julianne.mashke@spectranetics.com
Date: April 1, 2008
Job Title: QC/QA Manager
Location: Orange County
Salary: $50-80K + benefits
Responsibilities:
· Quality assurance and quality control specifications.
· Approving packages according to ASTM F963 standards.
· Conducting comparison research to insure compliance and safety.
· Analyzing products for safety and compliance according to State, Government and Industrial standards.
· Analyzing all factories and carriers for C-TPAT compliance.
· Analyzing all factories for Code of conduct compliance
Requirements:
· Candidate must also possess the ability to communicate well at all business levels.
· Previous experience in the TOY industry, as well as plastic contents analysis preferred.
· Familiarity of Code of Conduct requirements, product safety regulation and logistics and claims.
· Associates degree in any related field, and 1-3 years of related experience required
Respond to: Tomo Nakamura
tomo@tsconsult.com
Date: April 1, 2008
Job Title: Quality Engineer
Location: Inland Empire (Rancho Cucamonga)
Organization: Growing company (300 employees) in the aerospace hydraulics industry
Responsibilities:
· Perform product analyses, specification and program reviews, corrective actions, and other typical QE activities.
Requirements:
· Experienced applicants only
· Prefer ASQ CQE.
Respond to: Greg Burns
gregb@pneudraulics.com
Date: March 31, 2008
Job Title:
Three positions:
· Quality Systems Engineer 3 - (06-048)
· Quality Engineer 3 - Electronic Component & Mechanical Manufacturing - (07-118)
· Quality Engineer 2 - Electronic Components - (07-074)
Location: Torrance
Organization: L-3 Communications - Electron Technologies, Inc. (www.L-3Com.com)
Respond to: Apply via this link:
For Quality Systems Engineer 3 (06-048): https://www4.recruitingcenter.net/Clients/L3/PublicJobs/controller.cfm?jbaction=jobprofile&job_id=22483
For Quality Engineer 3 – Electronic Component & Mechanical Manufacturing (07-118):
For Quality Engineer 2 – Electronic Components (07-074): https://www4.recruitingcenter.net/Clients/L3/PublicJobs/controller.cfm?jbaction=jobprofile&job_id=31011
Or you may search all of L-3's position openings at:
http://www.l-3com.com/careers/search.aspx
Please note that we are not able to provide relocation at this time. If you live out of the area, you must be able to relocate at your own expense.
Date: March 18, 2008
Job Title: Engineering & Quality Assurance Manager
Location: Los Angeles County
Organization: Midsized, well-known bolt on automotive accessory manufacturer. This position will be based at their corporate headquarters in Southern California.
Responsibilities:
· Reporting to the V.P. Engineering & Quality Assurance.
· Develop, implement, and maintain a quality system that meets the company requirements.
· Constantly monitor and review product warranty attributes to pursue continuous improvement of the product lines.
· Supervise the quality engineer or supervisor at the manufacturing facilities and manage the third party quality resources employed to oversee the out source vendors.
· Train Company facility staff to perform tasks required to implement and support the quality system as reflected in the quality manual.
· Oversee the internal audit function, including: Training, Scheduling, Report Writing and Corrective Action Report follow up.
· Visit supplier facilities for the purpose of: identifying quality system deficiencies, and participate in the development of effective corrective action plans.
· Travel to the Company manufacturing locations, including Minnesota, during the course of the year. Additional international travel is required to vendors producing product for the Company in Taiwan, and China.
Requirements:
· Bachelor’s degree (B.S.) from a four year college or university in a technical field related to the areas of engineering, production planning, or manufacturing, or a closely related technical field.
· Experience with QS-9000/ ISO-9000 and TS-16949 based quality systems is desirable. Additionally, work experience in the 5 to 8 year range as a Manager is expected as a minimum requirement.
· Automotive industry / accessory experience desired in area of steel product fabrication involving steel plate, steel tube, fasteners, and the related coating processes.
· Additional experience in plastic component fabrication is valuable.
· Mandarin Chinese as a second language to English, is also highly desirable.
Respond to: Arleen Zuckerman
APA Search, Inc.
One Byram Brook Place
Armonk, NY 10504
azuckerman@apasearch.com
Fax: 914-273-8025
Phone: 914-273-6000
Date: March 13, 2008
Job Title: Aerospace Auditor
Salary: DOE
Location: Southern California
Organization: BSI, the world’s leading provider of ISO 9000 registration and certification
Responsibilities:
· Analyze quality systems and assess to ISO 9000 or AS requirements.
· Manage a portfolio of assigned clients based on location, a match of qualifications, and client contract requirements.
· Contacting clients and scheduling the visits, planning the assessments, making travel plans, conducting the assessments and reporting and managing the results.
· Leading teams, when necessary, and mentoring and coaching new or inexperienced colleagues as needed to meet the business needs.
Requirements:
· Qualified as an Aerospace AEA or AIEA.
· Should have knowledge in a variety of industry types to include: software, metals, machinery, chemicals, plastics, electrical, and business to business.
· RAB/QSA or IRCA Lead and 3rd party audit experience preferred.
· Environmental or Information security qualifications would be a plus.
· Strong compliance, research and writing skills.
Respond to: kathryn.crouch@bsigroup.com
For more detailed information about these and other positions please visit us at www.bsiamericas.com. and click on Career Opportunities. You may also email your resume in word (.doc) or (.txt) format to kathryn.crouch@bsi-global.com
Equal Opportunity Employer
Date: March 12, 2008
Job Title: Manager of Quality Assurance
Salary: DOE
Location: Irvine
Organization: IsoTis OrthoBiologics, a division of Integra LifeSciences Corporation
Responsibilities:
· Manage the Quality Assurance department to ensure quality system requirements are effectively implemented in accordance with FDA’s Quality System Regulation, EU ISO 13485, Medical Device Directives (MDD), Canadian and other applicable state and other countries regulations and quality requirements.
· Serve as Alternate Management Representative.
· Manage and provide direction to the Quality Assurance group. Develop and provide growth opportunities to Quality Assurance personnel.
· Provide guidance and interpretation of quality and regulatory issues for product development teams, assuring that design and development requirements are met; recommend, and implement compliance strategies for existing, new, and proposed products.
· Monitor/review internal/external audit noncompliance’s and act as Quality liaison in ensuring that all other departments meet their respective quality system standards, ensure that corrective actions identified through the process of audit or investigation are adequately validated and implemented.
· Assist Director of QA/RA and interfaces as required for inspections by FDA, ISO, AATB and all other regulatory/certification agencies.
Requirements:
· Medical Device or Biologics Manufacturing experience.
· Three to five years management expertise in Class II and/or III Medical Device Industry.
· Member ASQ.
· Comprehensive knowledge of the QSR and ISO requirements
Respond to: hr@isotis.com. Please state Quality Assurance Manager in the subject line.
No agencies please.
Fax: 949-595-8703
Date: March 5, 2008
Job Title: Software QA Engineer - SQAELA
Salary: DOE
Location: San Fernando Valley
Responsibilities:
· Represent QA Department in all software generation activities.
· Establish, implement and maintain a software validation program that conforms to the requirements and guidelines from US FDA, industrial standards (AAMI, IEEE, etc.), relevant European Council Directives (MDD and AIMDD) and International Standards (IEC, ISO, etc.).
· Generate and execute the software validation plans and reports.
· Foster supportive and productive relationships with groups external to Quality Assurance including but not limited to R&D, Regulatory, Production and Clinical Research.
· Conduct productive meetings and a work closely with the various R&D groups during product generation, validation and release for distribution.
· Risk Analysis processes
Requirements:
· BSEE/BSCS or equivalent a minimum.
· Minimum of five years working in a Software QA capacity.
· Experience in taking a new product through the various phases of development.
· Experience in preparing software for release and installation in a Production environment.
· Experience in troubleshooting software issues and documenting returned devices.
· Medical device experience preferred.
· Development and validation of medical devices preferred.
· Experience in hardware design and implementation is preferred.
Respond to: Cheryl Jones
recruit@medexecintl.com
818-552-2036
Date: March 5, 2008
Job Title: Supplier Quality Engineer - SUQELA
Salary: DOE
Location: San Fernando Valley
Organization:
Responsibilities:
· Evaluating and monitoring suppliers to ensure regulatory compliance as well as meeting company’s supplier performance goals.
· Lead Supplier Quality and Process Assessments, help drive systemic improvements and support site initiatives.
· Performing lead auditor function in the execution, management and closure of Quality Management System issues and perform Process audits (via travel) on suppliers that provide components assemblies and services or Finished Goods.
· Support all supplier related activities such as performance monitoring, creation and closure of supplier corrective actions (SCAR) and high level corrective action requests (CAPA).
· Maintain Database(s) that ensures all first article and qualification requirements have been met prior to material being released for production.
· Follow up on observations and recommendations with suppliers to resolve quality issues.
Requirements:
· BS degree in a technical discipline or equivalent experience.
· Two to five years experience in Quality Assurance with emphasis on Supplier Quality is required.
· Working knowledge of SPC, FMEA, and other quality improvement techniques is required.
· Working knowledge in manufacturing of medical devices and regulatory requirements is preferred.
· ASQ Certification preferred.
· Certificate in ISO 9001/ 2000 Lead Auditor preferred
Respond to: Cheryl Jones
cjones@medexecintl.com
Med Exec International
Phone: 818-552-2036 or 800-507-5277 ext 412
Email: cjones@medexecintl.com
http://www.medexecintl.comDate: March 5, 2008
Job Title: Sr. Microbiologist – SMBIOLA
Salary: DOE
Location: San Fernando Valley
Responsibilities:
· Manage the Company’s internal and external sterilization activities to ensure that they are conducted in compliance with regulatory requirements and to ensure that capacity requirements are planned for and met.
Requirements:
· BS/BA in a technical field required.
· 5-10 years experience in medical device sterilization. Must have in depth knowledge of the regulatory requirements for sterilization.
· 5-10 years experience in various aspects of device packaging and qualification.
· Product packaging experience.
· Sterilization theory and methods, especially ethylene oxide sterilization.
· Knowledge of national and international requirements for validation and maintenance of sterilization operations.
· Knowledge of national and international requirements for environmental monitoring of manufacturing facilities, and biocompatibility requirements for medical devices.
· Working knowledge of the methods and procedures for establishing and maintaining an environmental monitoring program.
· Working knowledge of the methods and procedures for establishing and maintaining a biocompatibility testing and evaluation program for medical devices.
· Demonstrated use of engineering tools/methodologies.
Respond to: Cheryl Jones
cjones@medexecintl.com
Med Exec International
Phone: 818-552-2036 or 800-507-5277 ext 412
Email: cjones@medexecintl.com
Date: March 5, 2008
Job Title: Quality Systems Auditor
Salary: DOE
Location: Riverside
Responsibilities:
· Audit, verify and follow-up of external suppliers.
· Management of third party and customer accreditation and audits.
· Insure that GMP and GLP are being followed.
· Post-audit activities.
· Coordinate and analyze all co-packed finished product samples.
· Develop raw material specifications.
· Develop Strategic Safety and Quality Review Programs.
· Packing site issues (e.g., site, raw materials, labeling, etc).
· HACCP and BRC Standards.
· Traceability and KPI reports
· Food safety hazards
Requirements:
· Bachelor’s Degree.
· Minimum two years experience in a similar role.
· Domestic and international travel requirements: 40% of the time.
· Bilingual English/Spanish preferable.
· Experience in beef and poultry cuts.
Respond to: Cheryl Jones
cjones@medexecintl.com
Med Exec International
Phone: 818-552-2036 or 800-507-5277 ext 412http://www.medexecintl.com
Date: February 28, 2008
Job Title: Supplier Quality Engineer
Salary: DOE
Location: San Diego
Organization: Maxwell Technologies, Inc.
Responsibilities:
· Reduces and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions.
· May be responsible for implementing product stops and documenting release criteria.
· Develops and implements product quality plans, documents and systems by creating product specifications, quality specifications, receiving inspection instructions, quality plans, risk analyses, FMEAs in conjunction with other product development team members.
· Develops and implements Process Monitoring Systems by identifying critical process steps which could culminate in possible sources of manufacturing defects and devising methods to reduce process variation in order to reduce/eliminate the cause of defects.
· Creates Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams.
Requirements:
· Three to five years of prior related manufacturing experience.
· Purchasing and Quality Assurance experience is beneficial to this position.
· Four year college degree required, preferably BS in Engineering, Quality or Supply Chain Management.
· ASQ Certification Preferred " Supplier Survey and Audit experience
Respond to: Chris Silva
csilva@maxwell.com
Date: February 27, 2008
Job Title: Sr. Quality Engineer
Salary: DOE
Location: Temecula
Organization: Abbott Vascular
Responsibilities:
· Create, identify, and implement new processes, technologies and enhancements to existing processes and technologies to foster and ensure consistent compliance to external laws, regulations, guidance, and standards that affect the quality system.
· Assist individuals, groups and teams on the impact of new systems and processes to the quality system and determine how to integrate these into the quality system.
· Determine Best Practices for Risk Management and implement new Risk Management system in accordance with ISO14971:2007.
· Identify areas of potential noncompliance within the existing Risk Management systems and determine remedies.
· Revise or create Quality System procedures for Risk Management. Identify and revise other related Quality Systems procedures that require modification as needed.
· Educate functional areas on the revisions to the Risk Management quality system requirements 5. Help mediate resolution of interdepartmental and cross business unit process conflicts.
· Help product teams to prepare Risk Assessments for new and existing products
Requirements:
· Technical or science related 4-year college degree, plus 6 or more years of Quality Engineering experience in a manufacturing environment.
· Medical device manufacturing experience is preferable.
Respond to: Sharlyn Maciel
sharlyn.maciel@av.abbott.com
Date: February 7, 2008
Job Title: Multiple positions (see Responsibilities section)
Salary: Open and very competitive
Location: Southern California
Organization: Medical Device company; implantable technology and Class III.
Responsibilities:
· Principal Engineer
· Quality Assurance Technician
· Quality Engineer
· Reliability Engineer
· Sr. Principal Digital Design Engineer
· Sr. Principal Algorithm Development Engineer Sr. Principal Analog Design
· Engineer Sr. Test Technician
Respond to: Thomas Carpenter. (Submit CV and indicate job in the subject line of your e-mail. All responses will be answered.)
Thomas J. Carpenter
Vice President
Svec Search
200 The Esplanade North B5
Venice, FL 34285
thomas@svecsearch.com
Fax: 630-578-0780
Date: February 6, 2008
Job Title: Director of Quality Assurance & Regulatory Affairs
Salary: DOE
Location: Irvine
Organization: IsoTis OrthoBiologics a division of Integra LifeSciences Corporation is a world leader in developing and marketing high quality surgical instruments, as well as innovative devices and products for use in neurosurgery, reconstructive surgery, general surgery and soft tissue repair.
Responsibilities:
· Provide leadership for compliance with quality and regulatory standards, ensuring that company-wide activities are performed in compliance with applicable standards and regulations.
· Ensures customer and regulatory requirements are established and met.
· Act as a liaison between the company and regulatory authorities for domestic and international regulatory application files.
· Functions as the Management Representative for the Quality System.
· Oversee the preparation and submission of regulatory applications (i.e. 501(k), IDE, PMA, Technical Files, Human Tissue product applications).
· Manage and oversee the requirements of the company for compliance with FDA, AATB, State Tissue Bank, and International regulations regarding human tissue based products.
· Monitor/review internal/external audit noncompliances.
Requirements:
· BS/MBA with 10 - 15 yrs of experience.
· Medical Device or Biologics Manufacturing experience.
· Five to seven years management expertise in Class II and/or III Medical Device Industry.
· Extensive experience in direct interaction with FDA and Notified Bodies.
· Regulatory Affairs Certified; Member RAPS.
· Member ASQ.
· Comprehensive knowledge of FDA Quality System regulations and ISO 13485:2003/MDD requirements, Canadian Medical Device Regulations, Medical Device Regulations in Japan and other international regulatory requirements.
· Knowledge of Tissue Bank Regulations
Respond to: hr@isotis.com.
Please state Director of Quality Assurance & Regulatory Affairs in the subject line.
Fax: 949-595-8703
www.integra-ls.com No agencies please.Date: February 6, 2008
Job Title: Quality Manager
Salary: DOE
Location: South Los Angeles
Organization: Manufacturing company that has clients in the Aerospace and Power generation industries.
Responsibilities:
· Applying advanced quality planning techniques to new and existing products.
· Establish proposed quality and reliability expectancy of finished product.
· Create and implement inspection criteria and procedures.
· Provide inspection activity for product throughout production cycle.
· Review CAD/AutoCAD drawings.
· Use statistical software (Minitab).
· Manage two quality engineers
Respond to: Kate Turner
kturner@msi1.com
Date: February 4, 2008
Job Title: Sr. Director Product Integrity
Salary: Mid-100K range plus 30% bonus
Location: Los Angeles
Organization: Internationally known, multi-billion dollar, high volume consumer products manufacturer.
Responsibilities:
· Establishment, maintenance and monitoring of the safety, quality, functional and aesthetics requirements for the company brands products worldwide during the design and development phase, the production phase and post production review of consumer input and product returns.
· Provides direction related to knowledge, interpretation and dissemination of safety regulations and standards for all brands and all geographic locations in which company brands products are produced and sold.
· Establishes and maintains systems that translate various regulations and standards from around the world into reasonable standards that then become company product specifications.
· Establishes and maintains testing standards, procedures and testing laboratories for ensuring compliance with product specifications for all brands.
· Review of quality and safety related complaints from consumers related to company brands products and the development of corrective action plans to minimize and eliminate occurrences.
· Review of product returns to determine root cause of defect and establishment of corrective plans for company brands, etc.
Respond to: Glenn Holland
The Holland Company (retained search firm)
4736 La Villa Marina, #F
Marina Del Rey, CA 90292
(310)301-9905
hollandg@ca.rr.com
Date: February 4, 2008
Job Title: Quality Assurance Document Administrator
Salary: DOE
Location: West Los Angeles
Organization: Leading manufacturer of medical and health related products in the West Los Angeles area. Competitive salary and benefits package.
Responsibilities:
· Maintaining department files and logs.
· Assisting with preparation of product submissions.
· Prepare, issue and maintain ISO controlled documents and quality reports and other clerical duties as required.
Requirements:
· Experience with ISO 9001 based quality system is preferred.
· High school graduate or equivalent.
· Proficient in Microsoft Word, Excel, Project and Power Point.
· Excellent communication and writing skills.
· Thorough understanding of computer logic and software applications.
· Detail oriented (proof reading, accuracy in typing and data entry).
Respond to: Human Resources
qadoc0108@yahoo.com
Fax: 310-841-0171
Date: January 31, 2008
Job Title: Sr. QA Engineer
Location: San Diego
Organization: Integra LifeSciences
Responsibilities:
· Directs and participates in quality assurance efforts to ensure that the Company’s products conform to quality standards and that processes and controls adhere to regulatory requirements.
· Resolves supplier quality issues with non-conforming raw materials and components by implementing CAPA.
· Supplier audits and vendor qualification and development.
· Develops and improves inspection techniques.
· Manages MRB process and ensures non conforming product is disposition in accordance with applicable regulatory requirements.
· Maintains Sterile Product and Sterilization Cycle validations.
· Responsible for the Environmental Monitoring Program of the CER.
· Participates and supports Corporate Product Development Process as related to supplier development/qualification, quality processes/tooling, and risk management activities such as FMEA.
· Oversees Calibration Program through direct supervision of technician.
· Develops and coordinates execution of process validation protocols and reports ensuring proper statistical analysis is applied.
· Supports the internal audit program as required.
Requirements:
· BSS EE or ME degree.
· 6 to 10 years medical device manufacturing in Quality Engineering.
· FMEA/SPC/Statistics/Validation experience.
· Knowledge/training of sterilization principles in accordance with EN 550 and ISO 11135:1994.
· CQE and CQA preferred
Respond to: Pauline Orbeta
Human Resources Department
5955 Pacific Center Blvd.
San Diego, CA 92121
jobs.sd@integra-LS.com
Salary requirements must be indicated on resume or cover letter.
Date: January 23, 2008
Job Title: Precision Inspector
Salary: Minimum of $19.50 per hour
Location: North Hollywood
Organization: Bobrick Washroom Equipment, Inc.
Responsibilities:
· Under minimal direction, performs inspection of purchased parts, sub-assemblies, manufactured parts, finished goods, first articles within the processes of receiving, in process, final and source inspections as well as stock audits.
· Performs inspection using dimensional, functional and visual attributes as required or specified, also, inspection Engineering prototypes, experimental parts and samples from new tooling as well as identification of metals, plastics, finish, plating, heat and spring testing.
· May perform calibration, inspection and maintenance of production or inspection gauges and equipment as well as complex set ups of inspection equipment and parts to ensure conformance to specifications.
· Assignments, communication and coordination with the lead person, and person will directly report to the QC/QA Manager or Supervisor.
· Analyze product process studies, internal or supplier process audits, data collections and analysis, filing and processing of inspection documentation and records, movement of parts and paperwork, work on team projects and other duties as assigned.
Requirements:
· Associate’s degree (A.A.) or equivalent from two-year college or technical school and three to four years related experience and/or training, or equivalent combination of education and experience.
· General knowledge in use of standard inspection tools such as micrometers, calipers, plug and ring gauges, gauge blocks, dial indicators, surface plate, profilometer and video measuring system.
· Familiarity with basic manufacturing process, (e.g., metal stamping and forming, machining, die, casting, plastic molding, heat treat and plating, welding, and finishing).
· Required, and prefer experience with the current quality tools and concepts, including SPC, TQM, and ISO
Respond to:
Employee Relations
Bobrick Washroom Equipment, Inc.
11611 Hart Street
North Hollywood, CA 91605
E-mail resumes to: jobs@bobrick.com
An Equal Opportunity Employer
Fax: 818-982-3942
Phone: 818-764-1000
Date: January 23, 2008
Job Title: Senior Quality Engineer
Salary: DOE
Location: Orange County
Responsibilities:
· Develop quality plans for new products.
· Implement process monitoring tools and develop periodic performance reports that will provide process status information, support improvement plans, and supplier control.
· Drive investigations for cause to negative yield impacts and resolve all manufacturing related issues that affect quality and reliability.
· Work on a team that will look to continually improve processes and products to ensure that Viking InterWorks supplies a high quality, reliable products to customers.
· Assist in the review of new product designs to ensure that products can be produced consistently at high yields.
· Generate ECOs and verify process implementation of design modifications to meet quality requirements.
· Process control, improvements, and validation.
· Validate new processes to ensure that quality requirements are consistently met.
· Establish performance requirements of test processes to satisfy new product requirements for production.
· Troubleshoot processes and assign corrective / preventive action details as necessary.
· Assist in developing process auditing instructions, reference documents, methods, etc. for existing and new processes.