Senior Quality Engineer
Posted 2 days 15 hours ago by Hero Recruitment
A leading regulated manufacturing organisation is seeking a Senior Quality Engineer - Compliance for a 12-month contract. This is a key technical role focused on ensuring manufacturing activities meet current global regulatory standards, including ISO 13485:2016 and EU MDR.
The successful candidate will play a central role in risk management, change control, and production quality support, acting as a key liaison between Quality and Operations.
Location: Mayo, Ireland
Sector: Medical Devices / Regulated Manufacturing
Discipline: Quality Assurance / Compliance
Key Responsibilities Risk Management- Lead and maintain risk management documentation, including pFMEAs
- Identify, assess, and mitigate potential failure modes across processes
- Provide on-the-floor QA support to manufacturing teams
- Manage non-conformances and lead root cause investigations
- Drive implementation of effective CAPAs (Corrective and Preventive Actions)
- Support internal and external audits
- Ensure compliance with cGMP and regulatory requirements
- Maintain accurate and audit-ready documentation
- Analyse process data using statistical tools (e.g. Minitab, Excel)
- Identify trends and support data-driven improvements
- Contribute to process optimisation and continuous improvement initiatives
- Support broader Quality Assurance activities as required
- Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, or related) or Life Sciences
- Minimum 2 years' experience in Quality Assurance or Validation within medical devices or a regulated industry
- Strong knowledge of:
- ISO 13485
- EU MDR
- ISO 14971
- Experience with root cause analysis tools (e.g. 5 Whys, Fishbone, FMEA)
- Strong analytical and problem-solving capabilities
- Excellent technical writing and communication skills
- Proficiency in tools such as Excel, Minitab, Power BI or equivalent
- ASQ Certified Quality Engineer (CQE) or equivalent
- Internal or Lead Auditor certification
- Lean / Six Sigma certification
- Broader knowledge of international medical device regulations
- High attention to detail and strong quality mindset
- Ability to manage multiple priorities in a fast-paced environment
- Strong cross-functional collaboration skills
- Proactive, self-driven, and continuous improvement focused
All applications will be treated in strict confidence. Opportunities are offered based on merit, skills, and experience, without regard to protected characteristics.