San Francisco Bay Area, CA
Senior Quality Engineer
San Francisco, CA
SUMMARY OF ROLE:
We are looking for a Design Quality Engineer with a passion for creating devices that save lives. This individual will support the product development team in product design and development in accordance with Design Control requirements. This individual will be responsible for providing quality support and oversight to ensure that the products are developed in compliance with company SOPs and other regulatory requirements. The candidate shall have excellent people skills and a can-do attitude to deliver solutions.
- Represent Quality Engineering in providing guidance to product development team through Design Control to ensure compliance to QSR for a life-saving electromechanical device.
- Develop verification and validation plan for new products and sustaining activities including Test Method Validation, Equipment Qualifications, etc.
- Develop test methods, document test protocols and reports to support V&V activities.
- Support NCR, CAPA, and Complaints process execution through root cause investigations.
- Support Supplier Quality activities.
- Execute systemic quality improvements based on quality metrics etc.
- Develop Risk Management Files per ISO 14971.
- Support improvement of Standard Operating Procedures and/or Work Instruction as part of the Quality System procedure.
- Function as an electrical design SME within the Quality team.
- Mentor junior engineers and other quality team members.
- Other tasks as assigned by the management.
- 7+ years of relevant experience in Medical Device environment.
- Working knowledge of current ISO 13485 standard, QSR, ISO 14971, and IEC 60601-1.
- Bachelor’s Degree in Science or Engineering, Master’s degree is a plus.
- Ability to work in a team environment, manage multi-tasking, and be disciplined in completing tasks on schedule.
- Excellent written and verbal communication skills.