Title: Sr. Quality Engineer for Swing Shift 2. Supervisor: QA Manager 3.
Location: Redwood City, CA 4. Purpose of Position: Supports production of clinical devices and process development. Maintains compliance to Medical Device Directives (MDD), ISO 13485, and Quality System Regulations for Design Controls.
Create protocols and reports for a device manufacturing and testing where needed. Perform specific data analysis and trending as required. Provide technical support to Manufacturing and R&D.
5. Essential Functions:
- Assists in assuring that Good Manufacturing Practice requirements are met, including Design Control.
- Performs review of production LHR and signoff as required.
- Reviews currently manufacturing process documentation and records.
- Works with Quality and Operations to maintain quality requirements in the support of clinical builds.
- Develops and implements specific testing for existing and new products including supporting process validations.
- Provides support to manufacturing inspection process development.
- Researches and provides guidance to the design team regarding standards and regulations applicable to the development project.
- Perform other duties in quality assurance as directed.
- Works in accordance with quality system procedures. 6. Minimum Education: BS/BA in an Engineering discipline preferred, equivalent combination of education and work experience acceptable. 7. Minimum Experience: 5 years of experience in Quality Engineering in the medical device industry. 8. Licenses, Certifications, and Registrations: ASQ Certified Quality Engineer certification preferred. 9. Other Essential Knowledge, Skills, and Abilities:
- Must have strong oral and written communication skills.
- Strong knowledge in the use of manufacturing processes used in the medical device industry.
- Strong knowledge of statistical data analysis.
- Working knowledge of FDA QSR, EN/ISO 13485 and EN/ISO14971. 10. Working Environment: Job duties are typically performed in an office environment. Overall duties require the ability to stand or sit for lengthy periods of time in a lab. Required duties include utilizing standard office equipment such as a computer, photocopier, and telephone, and reading and writing. 11. Travel (if any): Some out of town travel be required for supplier interactions (anticipated to be 10% of time) 12. Personal Protective Equipment: Latex/rubber/heat resistant gloves, UV eye protection, safety glasses, goggles, respirators, splash aprons, cleanroom gowning wear (smocks, head covers, beard covers, shoes covers)
Minimum Education: BS/BA in an Engineering discipline preferred, equivalent combination of education and work experience acceptable. Minimum Experience: 5 years of experience in Quality Engineering in the medical device industry. Licenses, Certifications, and Registrations: ASQ Certified Quality Engineer certification preferred.
Other Essential Knowledge, Skills, and Abilities:
- Must have strong oral and written communication skills.
- Strong knowledge in the use of manufacturing processes used in the medical device industry.
- Strong knowledge of statistical data analysis.
- Working knowledge of FDA QSR, EN/ISO 13485 and EN/ISO14971.
9. Other Essential Knowledge, Skills, and Abilities:
- Must have strong oral and written communication skills.
- Strong knowledge in the use of manufacturing processes used in the medical device industry.
- Strong knowledge of statistical data analysis.
- Working knowledge of FDA QSR, EN/ISO 13485 and EN/ISO14971.