Quality Assurance Specialist - Manufacturing
Reperio has partnered with a rapidly growing medical device company to support quality assurance across manufacturing processes and external suppliers.
Responsibilities:
* Oversee manufacturing quality for electronic and system-level production.
* Lead root cause investigations and manage corrective actions.
* 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 Quality, or a related field.
* 3-7 years in QA or manufacturing in a regulated industry (preferably medical devices).
* Experience with corrective actions, non-conformances, and process validation.
* Strong knowledge of ISO 13485 and FDA QSR.
* Excellent communication skills and attention to detail.
Desirable:
* Experience with contract manufacturers.
* Certifications (CQE, Six Sigma, Auditor).
* Familiarity with Quality Management Systems (QMS)/Enterprise Resource Planning (ERP) systems.
For more information contact Seamus at Reperio or apply through the link.
Seamus O'Rawe is recruiting for this role.
Get in touch with Seamus O'Rawe for more information: