Senior Manufacturing QA
163142
Desired skills:
QA, Quality Assurance, Manufacturing, Medical Devices
Reperio has partnered with a rapidly growing medical device company who are seeking a Senior Manufacturing QA to support quality assurance across manufacturing processes and external suppliers, including contract manufacturers.
Responsibilities:
1. Oversee manufacturing quality for electronic and system-level production
2. Lead root cause investigations and manage CAPAs
3. Support process validations (IQ/OQ/PQ) and documentation reviews
4. Manage supplier quality performance and participate in audits
5. Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and related standards
6. Drive continuous improvement and support internal/external audits
Requirements:
7. Bachelor's degree in Engineering, Quality, or a related field
8. 3-7 years in QA or manufacturing in a regulated industry (preferably medical devices)
9. Experience with CAPA, non-conformances, and process validation
10. Strong knowledge of ISO 13485 and FDA QSR
11. Excellent communication skills and attention to detail
Desirable:
12. Experience with contract manufacturers
13. Certifications (CQE, Six Sigma, Auditor)
14. Familiarity with QMS/ERP systems (., Greenlight Guru, MasterControl)
For more info contact Seamus at Reperio or apply through the link
Reperio Human Capital acts as an Employment Agency and an Employment Business.
Seamus O'Rawe is recruiting for this role.
Get in touch with Seamus O'Rawe for more information: