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Senior manufacturing qa - medical devices

Reperio Human Capital
Manufacturing
€80,000 - €100,000 a year
Posted: 30 July
Offer description

Senior Manufacturing QA - Medical Devices

171718

Desired skills:
QA, QMS, RA, Medical Devices, Galway

Hybrid

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.


Responsibilities:

* Oversee quality for electronics/system-level manufacturing with CMs
* Lead investigations and CAPA for non-conformances
* Support IQ/OQ/PQ validations and documentation reviews
* Monitor supplier quality and contribute to audit preparedness
* Collaborate on regulatory submissions and inspection readiness


Requirements:

* Degree in Engineering, Quality, or a related discipline
* 3-7 years in QA or manufacturing quality within a regulated industry
* Strong knowledge of ISO 13485, FDA QSR, and process validation
* Experience supporting regulatory audits or working with Regulatory Affairs teams
* 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.

Why not send us your CV to be kept up to date with the latest jobs or to have an initial discussion with one of our Consultants.

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