Sr. Supplier Quality Engineer
CyberCoders

Sr. Supplier Quality Engineer If you are a Supplier Quality Engineer with medical device industry experience, please read on!

* Job Title:* Sr. Supplier Quality Engineer
* Location:* Sunnyvale, CA (hybrid position)
* Requirements:* 5+ years of quality engineering experience in medical device industry / Experience leading or participating in supplier audits

This would be an amazing opportunity for you if you are looking to grow your medical device career with a top company!

*Additional ways in which a candidate may stand out would be:*
- Solid understanding of ISO 13485, EU MDD/MDR, FDA QSR Part 820, risk management (ISO 14971) and other applicable standards
- Trained Lead Auditor experience
- Prior experience in manufacturing environment, validation and sterilization is advantageous
What You Will Be Doing - Visit vendor facilities and observe the manufacturing and distribution environments to review and assess their processes and procedures
- Conduct supplier audits to ensure vendors continue to work in compliance with company and regulatory standards
- Review incoming supplies and finished goods from vendors to check for defects, ensure quality and authorize release
- Investigate and resolve supplier non-conformances, complaints and CAPAs leading to satisfactory closure
- Manage supplier management program, including establishment and maintenance of supplier file and monitoring of supplier performance
- Conduct tests and assessments on products to identify quality issues
- Maintain detailed reports on supplier quality, including defect rates and areas that result in flaws
- Provide technical advice and guidance to suppliers to reduce defect rates
- Conduct internal audits, as needed, and support external regulatory body audits
- Serve as a liaison between senior management and vendors to identify quality issues and come up with solutions
- Evaluate product and process changes initiated by R&D, Operations, and/or contract manufacturers
- Assist with development of required documentation to support changes
What's In It for You - Competitive Salary
- Medical
- Dental
- Vision
- Unlimited Paid Time Off
- Holiday Pay
- 401K w/match
We are ACTIVELY interviewing, so please apply today!
- Applicants must be authorized to work in the U.S.



*CyberCoders, Inc is proud to be an Equal Opportunity Employer*



All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.



*Your Right to Work* - In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.