Sr. Manager Quality Engineer
$190,000–$210,000 year
On-siteCampbell, California, United States
Job Summary
Lead the Supplier Quality Engineering group and Contract Manufacturing Quality to manage materials, processes, and systems for medical device products. Direct collaboration with suppliers and OEMs to ensure compliance with ISO 13485, FDA, and other regulatory standards. Manage all employee activities including resourcing, hiring, and mentoring staff while overseeing incoming inspection teams and component acceptance criteria. Spearhead supplier audits, requalification processes, and non-conformance investigations to drive resolution of quality issues and risk control. Monitor supplier performance metrics, manage SCARs, and lead project management activities for compliance and quality initiatives. Present supplier-related issues to management and support internal and external audits.
Required Qualifications
- BS in Engineering or related discipline and 8+ years of supplier quality experience
- MS in Engineering with 6+ years of related experience
- equivalent combination of education and work experience in the medical device or related regulated industry
- 2+ years of supervisory experience
- Experience leading supplier or process issues (CAPAs, NCRs, SCARs, etc.)
- Must have strong knowledge of quality system requirements (FDA 21 CFR Part 820, ISO 13485)
- risk management standards (ISO 14971)
- good manufacturing practices
- Must be able to write clear, concise, and well thought out technical documentation
- Ability to communicate effectively, both orally and in writing, with all organizational levels
- Strong attention to detail and ability to function in a fast-paced dynamic environment
Desired Qualifications
- Lead auditor certification a plus
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