Quality Engineer: Risk & PFMEA Leader

Sanmina Corporation; Cork; On-site; EUR 65,000 - 95,000; Full time

Job summary

Sanmina Fermoy in Ireland is seeking a Quality Engineer - Risk Management to lead risk assessment and investigations in a Class III medical device environment. The role interfaces with the Head of Quality and supports FDA QSR, ISO13485 compliance and ISO14971 risk management.

Responsibilities include leading investigations into non-conformances, driving PFMEA mitigation, developing SOPs and QA plans, supporting NPI, conducting internal audits, and mentoring site teams on risk-based thinking.

Qualifications

• NFQ Level 8 degree in Science/Engineering or equivalent.
• 5+ years in Quality Assurance & risk management in Class 3 medical devices.
• Working knowledge of FDA QSR, ISO 9001, ISO 13485, and Medical Device Directive.
• Six Sigma Green or Black Belt certification.
• Advanced proficiency in SPC and MS Office.
• Strong communication and cross-functional collaboration.

Responsibilities

• Lead end-to-end Quality support for manufacturing, managing investigations into potential material and process non-conformances.
• Manage team to achieve best in class risk mitigation and drive effective Event investigation process.
• Drive PFMEA risk mitigation and closed-loop investigation processes under change control.
• Generate and analyze Quality metrics using statistical tools to support risk mitigation across all sub-processes.
• Develop and approve SOPs, Quality Plans, FMEAs, and Control Plans.
• Support NPI and QSR Validation protocols (IQ/OQ/PQ).
• Conduct internal audits and participate in regulatory agency inspections regarding risk/event management rationales.
• Manage the Event Investigation Forum, monitoring weekly data and implementing problem-solving techniques.
• Ensure ongoing compliance with Health, Safety, and industry regulatory requirements.
• Conduct ISO 14971 Risk management training on site and provide mentorship as required.

Skills

Six Sigma Green Belt

Six Sigma Black Belt

MS Office

SPC

Cross-functional collaboration

Education

NFQ Level 8 Degree in Science/Engineering or equivalent

Tools

SPC

Microsoft Excel

Job description

Sanmina Fermoy in Ireland is seeking a Quality Engineer - Risk Management to lead risk assessment and investigations in a Class III medical device environment. The role interfaces with the Head of Quality and supports FDA QSR, ISO13485 compliance and ISO14971 risk management.

Responsibilities include leading investigations into non-conformances, driving PFMEA mitigation, developing SOPs and QA plans, supporting NPI, conducting internal audits, and mentoring site teams on risk-based thinking.