Senior Manufacturing QA

2 weeks ago

Galway, Ireland Reperio Human Capital Full time

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 CMsLead investigations and CAPA for non-conformancesSupport IQ/OQ/PQ validations and documentation reviewsMonitor supplier quality and contribute to audit preparednessCollaborate on regulatory submissions and inspection readiness

Requirements:

Degree in Engineering, Quality, or a related discipline3-7 years in QA or manufacturing quality within a regulated industryStrong knowledge of ISO 13485, FDA QSR, and process validationExperience supporting regulatory audits or working with Regulatory Affairs teamsAdvantageous: 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:

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