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Senior Manufacturing Qa

4 weeks ago

Galway, Ireland Reperio Human Capital Full time

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Senior Manufacturing QA - Medical Devices, Galway
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Client:
Location:
Galway, Ireland
Job Category:
Other
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EU work permit required:
Yes
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Job Reference:
d435d760bb7f
Job Views:
10
Posted:
Expiry Date:
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Job Description:
Senior Manufacturing QA - Medical Devices
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:
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.
Senior Manufacturing QA - Medical Devices
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:
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.Get in touch with Seamus O'Rawe for more information: #J-18808-Ljbffr