Iso jobs in Galway at Collins mcnicholas 11 -20 of 21 (0.000s)

Senior regulatory specialist

GalwayCollins McNicholas

...with risk management (EN ISO 14971). Strong knowledge of FDA QSR (21 CFR 820), EU MDD, and relevant standards. Prior experience with US FDA submissions is a plus.For a confidential discussion and more information on the role contact Courtney Russell.+353 (0) 71 9108062 [...]

Category Fashion & Arts

24 days ago in Collins McNicholas

Design assurance quality specialist

GalwayCollins McNicholas

...processes. Ensure compliance with ISO 13485:2016, 21 CFR 820, and internal QMS requirements. Monitor QMS performance, assist with audits, and contribute to Management Review. Create technical plans and reports for internal and regulatory use. Support audit readiness and close audit actions promptly. Oversee Contract [...]

Category Fashion & Arts

30+ days ago in Collins McNicholas

Qa manager

GalwayCollins McNicholas

...QMS in line with ISO 13485:2016 and 21 CFR 820. Act as Quality Management Representative and support audit readiness, audit management and closure of actions. Oversee quality processes including non-conformances, CAPA and supplier quality. Provide quality leadership across the organisation and ensure compliance throughout the [...]

Category Banking, Insurance, Finance & Accountancy

30+ days ago in Collins McNicholas

Financial accountant

GalwayCollins McNicholas

...in collaboration with external advisors. Manage external audits, providing detailed reconciliations and audit trails. Contribute to process improvement and system enhancements within the finance function.Requirements: Bachelor’s degree in Accounting, Finance, or a related discipline. Professional qualification: ACA/ACCA. [...]

Category Banking, Insurance, Finance & Accountancy

30+ days ago in Collins McNicholas

General manager - r&d centre of excellence

GalwayCollins McNicholas

...medical device standards (e.g., ISO 13485, MDR, FDA). Team Development: Recruit and manage interdisciplinary teams, fostering a culture of growth and excellence.Requirements; Master’s or Ph.D. in engineering, materials science, or biomedical fields. 10+ years in R&D and leadership within the medical device industry, [...]

Category Management & Consulting

30+ days ago in Collins McNicholas

Manufacturing engineer

GalwayCollins McNicholas

...are compliant with GMP, ISO 13485, and regulatory standards.Candidate Requirements Degree in Engineering, Manufacturing, Biomedical, Mechanical, or a related discipline. Minimum 2 years’ experience in a regulated manufacturing environment, ideally medical devices. Strong knowledge of GMP, process validation, and manufacturing [...]

Category Engineering & Architecture

30+ days ago in Collins McNicholas

Senior quality engineer

GalwayCollins McNicholas

...risk in line with ISO 14971. Oversee supplier qualification, audits, and non-conformance management. Approve batch release, product disposition, and key quality decisions.Knowledge, Skills and Experience Required for the Role: Degree in Engineering, Science, or related field. 5+ years’ experience in Medical Device or Pharma [...]

Category Manufacturing & Production

30+ days ago in Collins McNicholas

Qa manager

GalwayCollins McNicholas

...will ensure compliance with ISO 13485, 21 CFR 820, and EU MDR while driving continuous improvement. Ideal for an experienced Quality Manager or Senior Quality Engineer ready to step into leadership.Overview of your responsibilities (full job description available on request) Lead, develop, and support the Quality Engineering [...]

Category Manufacturing & Production

30+ days ago in Collins McNicholas

Manufacturing technician

GalwayCollins McNicholas

...of quality standards, including ISO 13485, MDR, and FDA Requirements. 2-5 years hands-on experience in the Medical device/pharma industry, operating and maintaining production equipment and supporting process improvementsFor a confidential discussion on the Manufacturing Technician role, please contact Emma Barry today.091 [...]

Category Manufacturing & Production

30+ days ago in Collins McNicholas

Senior quality engineer

GalwayCollins McNicholas

...line with FDA and ISO requirements.Knowledge, Skills and Experience Required for the Role: Degree in Engineering, Life Sciences, or related field Level 8 Degree in Science, Engineering, Quality or similar. 5+ years’ experience in the medical device industry. Strong knowledge of quality systems, measurement techniques, FDA & [...]

Category Engineering & Architecture

30+ days ago in Collins McNicholas