Our company is seeking a Senior Manufacturing QA to support quality assurance across manufacturing processes and external suppliers, including contract manufacturers.
Responsibilities:
* Oversee manufacturing quality for electronic and system-level production
* Lead root cause investigations and manage CAPAs
* Support process validations (IQ/OQ/PQ) and documentation reviews
* Manage supplier quality performance and participate in audits
* Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and related standards
* Drive continuous improvement and support internal/external audits
Requirements:
* Bachelor's degree in Engineering or a related field
* 3-7 years 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 qualifications include experience with contract manufacturers, certifications such as CQE, Six Sigma, and Auditor, and familiarity with QMS/ERP systems.
Reperio Human Capital acts as an Employment Agency and an Employment Business.
For more information contact Seamus at Reperio or apply through the link