Senior Quality Engineer

Overview

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

Production Quality Support

• 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)

Audit & Compliance

• Support internal and external audits
• Ensure compliance with cGMP and regulatory requirements
• Maintain accurate and audit-ready documentation

Data Analysis & Continuous Improvement

• 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

Additional Duties

• Support broader Quality Assurance activities as required

Requirements Essential

• 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

Desirable

• ASQ Certified Quality Engineer (CQE) or equivalent
• Internal or Lead Auditor certification
• Lean / Six Sigma certification
• Broader knowledge of international medical device regulations

Key Competencies

• 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

Equal Opportunity Statement

All applications will be treated in strict confidence. Opportunities are offered based on merit, skills, and experience, without regard to protected characteristics.