Lead Quality Engineer — Medical Devices & CAPA Expert

Freudenberg Group; Spiddal; On-site; EUR 70,000 - 90,000; Full time

Job summary

Freudenberg Group is seeking an experienced quality leader in Ireland to drive the Quality System and CAPA program for Freudenberg Medical Ireland. You will lead audits, manage a small team, and ensure regulatory compliance across ISO 13485 and FDA requirements.

You will document procedures, review measurements and participate in cross-functional projects to ensure product quality and customer satisfaction. A proactive, detail-oriented professional is essential for success.

Qualifications

• Degree or diploma in engineering, science or quality in medical devices.
• Minimum 5 years in a similar quality role.
• Strong attention to detail and excellent communication.
• Good knowledge of ISO 13485 and FDA requirements.
• Proven problem-solving with Six Sigma green belt or higher.
• Understanding of lean principles; green belt is an advantage.
• Ability to lead and develop a small team.

Responsibilities

• Identify customer requirements and document them in Freudenberg Medical docs.
• Ensure Quality System compliance with customer and regulatory needs.
• Review incoming, in-process and final inspection plans regularly.
• Investigate quality issues and customer complaints; apply CAPA.
• Assess changes/deviations/reworks for impact on quality and validation.
• Dispostions and update specs/visual standards as needed.
• Validate processes; write protocols, reports and test records.
• Lead quality audits and supplier audits; support customer audits.
• Document procedures and approve updates; manage documentation.
• Use data to identify improvements and implement them ongoing.
• Supervise staff (up to 4) and mentor the team.
• Collaborate with customers and suppliers on quality issues and new products.
• Participate in project teams and meet schedule and budget commitments.
• Adhere to OH&S, environmental and energy management policies.

Skills

People management

Attention to detail

Quality systems

Effective communication

Problem solving

Continuous improvement

Ability to learn

Education

Degree / Diploma in Engineering, Science and/or Quality

5+ years in a similar role

Six Sigma Green Belt or higher

Lean Green Belt

Job description

Freudenberg Group is seeking an experienced quality leader in Ireland to drive the Quality System and CAPA program for Freudenberg Medical Ireland. You will lead audits, manage a small team, and ensure regulatory compliance across ISO 13485 and FDA requirements.

You will document procedures, review measurements and participate in cross-functional projects to ensure product quality and customer satisfaction. A proactive, detail-oriented professional is essential for success.