Quality Engineer III / Sr. Quality Engineer

Company DescriptionJOHNSON & JOHNSON / CALIBRA Job DescriptionTitle: 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)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 Information9. 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. SummaryType: ContractFunction: ManufacturingExperience level: Mid-Senior LevelIndustry: Pharmaceuticals