Senior Manufacturing QA Professional
Reperio has partnered with a rapidly growing medical device company seeking a Senior Manufacturing QA to support quality assurance across manufacturing processes and external suppliers.
The ideal candidate will oversee manufacturing quality for electronic and system-level production, lead root cause investigations, and manage CAPAs. They will also support process validations (IQ/OQ/PQ) and documentation reviews, manage supplier quality performance, and ensure compliance with ISO 13485 and FDA 21 CFR Part 820.
Key Responsibilities:
* Oversight of manufacturing quality for electronic and system-level production
* Leading root cause investigations and managing CAPAs
* Supporting process validations (IQ/OQ/PQ) and documentation reviews
* Managing supplier quality performance
* Maintenance of compliance with relevant regulatory standards
Requirements:
* Bachelor's degree in Engineering, Quality, or a related field
* 3-7 years of experience in QA or manufacturing in a regulated industry (preferably medical devices)
* Experience with CAPA, non-conformances, and process validation
* Strong knowledge of ISO 13485 and FDA QSR
* Excellent communication skills and attention to detail
Desirable Skills:
* Experience with contract manufacturers
* Certifications (CQE, Six Sigma, Auditor)
* Familiarity with QMS/ERP systems
This role presents an exciting opportunity for a skilled professional to make a significant impact on the company's quality assurance efforts.