Director of Quality
Fremont, CA 94538 US
- Bachelor’s Degree in Mechanical, Manufacturing, or Industrial Engineering preferred
- Ideal candidate will have 8+ years of industry experience in quality or regulatory role. At least 4 years of experience in the medical device industry
- Certified Quality Auditor
- Previous experience hosting FDA, ISO 13485, ISO 9001, and clean room audits
- Experience with Design History Reviews, Lot Reviews, etc.
- Experience with sending products out for sterilization with ETO and if possible also other methods such as X-ray and E-Beam
- Strong communication and negotiation skills
- Manage and update QMS according to customer requirements and maintain compliance with ISO 13495, 21CFR820
- Serve as regulatory expert to existing and prospective clients; demonstrate expertise in medical standards, manufacturing, and compliance with regulatory bodies
- Manage suppliers to ensure compliance standards are met
- Collaborate with internal team and vendors on solutions to timeline issues and changes in customer requests
- Serve as representative for quality audits and inspection by competent authorities, notified/regulatory bodies, customers, and other third parties. Audits include manufacturing lines and clean rooms.
- Consult clients on how manufacturing can be done efficiently and compliance with quality standards
- Create reports on performance of quality system and advise on improvements to be made