Senior Manufacturing QA - Medical Devices
171718
Desired skills:
QA, QMS, RA, Medical Devices, Galway
Senior Manufacturing QA Engineer - Medical Devices
Location: Galway / Hybrid | Type: Permanent | Sector: Medical Devices | Salary: Competitive
An innovative and fast-scaling medical device company is seeking a Senior Manufacturing QA Engineer to support commercial manufacturing of a cutting-edge connected health solution for chronic wound care.
This role is ideal for a quality professional with experience in manufacturing, supplier oversight, and regulatory compliance. You'll work across internal operations and contract manufacturing to ensure product quality, compliance with ISO 13485 / FDA 21 CFR 820, and readiness for regulatory inspections.
Key Responsibilities:
1. Oversee quality for electronics/system-level manufacturing with CMs
2. Lead investigations and CAPA for non-conformances
3. Support IQ/OQ/PQ validations and documentation reviews
4. Monitor supplier quality and contribute to audit preparedness
5. Collaborate on regulatory submissions and inspection readiness
Requirements:
6. Degree in Engineering, Quality, or a related discipline
7. 3-7 years in QA or manufacturing quality within a regulated industry
8. Strong knowledge of ISO 13485, FDA QSR, and process validation
9. Experience supporting regulatory audits or working with Regulatory Affairs teams
10. Advantageous: Contract manufacturing experience, CQE, Six Sigma, or auditing certifications
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: