
Senior Medical Device Quality Remediation Specialist
1 week ago
We are seeking an experienced Quality Engineer to support a critical site-wide remediation program following an FDA 483. This role offers a fantastic opportunity to work directly onsite, collaborating closely with manufacturing and quality teams to drive compliance improvements and process validation initiatives.
Key Responsibilities- Partner with manufacturing process owners to identify and remediate compliance gaps.
- Support manufacturing process validation activities (IQ/OQ/PQ).
- Update quality system documentation and technical files to ensure audit readiness.
- Drive closure of CAPAs and NCRs with effective corrective actions.
- Provide clear and concise technical writing for quality and manufacturing procedures.
- Bachelor's degree in Engineering or Quality-related discipline.
- 25 years of experience in medical device manufacturing, quality, or remediation projects.
- Strong knowledge of process validation (IQ/OQ/PQ) and CAPA/NCR management.
- Proven technical writing and documentation skills.
- Familiarity with 21 CFR Part 820 and ISO 13485 quality standards.
- Excellent problem-solving skills with the ability to take a problem statement through to a compliant solution.
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Remediation Quality Engineer
4 days ago
Galway, Galway, Ireland Oxford Global Resources Full timeOverviewOur client, a leading medical technology company in Galway, is seeking experiencedRemediation Quality Engineers / Manufacturing Engineersto support a critical site-wide remediation program following an FDA 483 observation.This role offers a fantastic opportunity to work directly onsite, collaborating closely with manufacturing and quality teams to...
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Remediation Quality Engineer
5 days ago
Galway, Galway, Ireland Oxford Global Resources Full timeOverviewOur client, a leading medical technology company in Galway, is seeking experienced Remediation Quality Engineers / Manufacturing Engineers to support a critical site-wide remediation program following an FDA 483 observation. This role offers a fantastic opportunity to work directly onsite, collaborating closely with manufacturing and quality teams to...
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Remediation Quality Engineer
4 days ago
Galway, Galway, Ireland Oxford Global Resources Full timeOverviewOur client, a leading medical technology company in Galway, is seeking experienced Remediation Quality Engineers / Manufacturing Engineers to support a critical site-wide remediation program following an FDA 483 observation. This role offers a fantastic opportunity to work directly onsite, collaborating closely with manufacturing and quality teams to...
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Medical Device Quality Leader
3 days ago
Galway, Galway, Ireland beBeeDesign Full time €90,000 - €110,000Lead Quality Assurance SpecialistAbout the RoleThe Lead Quality Assurance Specialist will be responsible for ensuring the highest quality of medical devices, adhering to regulatory requirements and industry standards. This role involves collaborating with cross-functional teams to develop sterile and non-sterile medical devices.Main ResponsibilitiesRisk...
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Medical Device Quality Assurance Specialist
7 days ago
Galway, Galway, Ireland beBeeQuality Full time €63,000 - €93,000Job Description:We are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality and compliance of our medical devices. Your primary objective will be to identify and mitigate potential quality risks, ensuring that our products meet the highest standards of...
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Quality Assurance Specialist
3 days ago
Galway, Galway, Ireland beBeeCompliance Full time €80,000 - €120,000We are seeking an experienced Quality Engineer to join our team. This individual will play a critical role in ensuring the highest standards of quality and compliance across medical device manufacturing operations.Key ResponsibilitiesThe successful candidate will be responsible for partnering with manufacturing process owners to identify and remediate...
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Senior Medical Device Compliance Specialist
4 days ago
Galway, Galway, Ireland beBeeRegulatory Full time €68,000 - €86,000Regulatory Affairs SpecialistJob Description:The Regulatory Affairs Specialist will be responsible for managing the regulatory and vigilance process, preparing regulatory submissions, maintaining technical files, and supporting quality and regulatory management.Manage the regulatory and vigilance process to ensure compliance with EU, UK, and FDA...
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Senior Medical Device Quality Engineer
3 days ago
Galway, Galway, Ireland beBeeQuality Full time €80,000 - €150,000Thriving quality engineer sought for 6-month contract position in medical device manufacturing. A seasoned professional with extensive experience in process validation, CAPA/NCR management, and problem-solving is required to lead our team.">Key ResponsibilitiesCollaborate with manufacturing process owners to identify and rectify compliance gaps.Support...
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Senior Medical Device Compliance Specialist
6 days ago
Galway, Galway, Ireland beBeeRegulatory Full time €75,000 - €105,000Job DescriptionA highly experienced Regulatory Affairs Specialist is sought to join a key role in Galway.This role will work closely with cross-functional teams to obtain regulatory approvals for a new medical device therapy.Support and advise the Quality leadership on regulatory activities and strategies.Develop and submit high-quality regulatory documents...
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Galway Medical Device Production Specialist
3 days ago
Galway, Galway, Ireland beBeeManufacturing Full time €60,000 - €80,000Manufacturing Engineer - Galway, IrelandWe are seeking an experienced Manufacturing Engineer to join our team in Galway, Ireland. As a key member of our manufacturing team, you will be responsible for ensuring the efficient and effective production of high-quality medical devices.Job DescriptionThis is an exciting opportunity to work with a global leader in...