QA Engineer - Risk Management

QA Engineer - Risk Management Department

Quality

Reporting To

Head of Quality

Objectives of Position

The Risk & Event Lead ensures customer accounts utilize robust Risk Management and Event Investigation tools to drive continuous process improvement.

This role serves as the principal interface for risk mitigation (PFMEA) and investigation alignment within Sanmina Ireland UC, ensuring strict adherence to FDA Quality System Regulations and international standards.

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 approach and drive effective Event investigation process.
• Drive "live" PFMEA risk mitigation and closed-loop investigation processes to ensure site-wide compliance 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) ensuring best-in-class risk planning.
• 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.

Quality

Assure ongoing compliance with quality and industry regulatory requirements.

Health & Safety

Ensure compliance with Health & Safety Legislation and Regulations.

Measurement

• Timely closure of Open EIFs (target
• PFMEA accuracy and zero audit findings in Risk Management tools.
• EIF effectiveness related to trend improvement in Key metrics including trend review and reduction across NCMR activity in each account.

Personnel Specifications Qualifications and Experience

• NFQ Level 8 Degree in Science/Engineering or equivalent experience.
• 5+ years in Quality Assurance & risk management environment within Class 3 Medical Device environments.
• Working knowledge of current FDA Quality Systems Regulation, ISO 9001, ISO 13485, and the Medical Device Directive required.
• Six Sigma Green or Black Belt Certification.
• Advanced proficiency in statistical tools (SPC, trend analysis) and Microsoft Office.
• Strong communication and influencing skills with cross functional teams.

Core Competencies

• Must have in-depth knowledge of Risk Management standard ISO 14971
• Excellent communication and influencing skills are essential.
• Good understanding of Quality and Regulatory requirements related to the medical device industry.
• Good analysis and problem solving skills.
• Ability to work in high paced aggressive environment with ability to lead change in a compliant manner.