Quality Engineer III / Sr. Quality Engineer
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 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.
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)
Qualifications
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.
Additional Information
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.