Quality Assurance Specialist
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 action plans
* Support process validations (IQ/OQ/PQ) and documentation reviews
* Manage supplier quality performance and participate in audits
* Ensure compliance with regulatory standards
* Drive continuous improvement and support internal/external audits
Requirements:
* Bachelor's degree in Engineering, Quality, 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:
* Experience with contract manufacturers
* Certifications (CQE, Six Sigma, Auditor)
* Familiarity with QMS/ERP systems (e.g. Greenlight Guru, MasterControl)
This is a great opportunity to work in a dynamic and fast-paced environment.
Contact Seamus O'Rawe for more information.