Senior Quality Manager – Medical Devices & ISO 13485

Freudenberg Group; Spiddal; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Health Insurance

Performance Related Bonus

Flexible Work Models

Diversity & Inclusion

Job summary

Freudenberg Medical Ireland Ltd. is seeking a Quality Manager to lead quality assurance in a highly regulated medical device manufacturing environment. You will own CAPA, audits, change control and supplier quality to ensure compliance and product safety.

We value hands-on leadership, Lean Six Sigma, data-driven decision making and strong collaboration with customers, suppliers and regulators to drive practical improvements.

Qualifications

• Bachelor’s degree in Engineering, Quality, Manufacturing or a related discipline.
• Minimum of 10 years’ progressive experience in a relevant manufacturing environment, ideally within medical devices or another highly regulated industry.
• At least 3 years’ successful experience directly managing and developing employees, including performance management, coaching and team development.
• Strong knowledge of medical device Quality Management Systems, ISO 13485 and applicable FDA regulatory requirements.
• Proven expertise across core quality processes, including CAPA, complaint handling, internal auditing, change management and validation.
• Experience applying Lean, Six Sigma and Quality Assurance methodologies to deliver practical, sustainable improvements.
• Strong analytical and problem-solving skills, with the ability to interpret data and apply statistical tools such as Minitab.

Skills

Lean Six Sigma

Analytical skills

Problem solving

Communication

Collaboration

Education

Bachelor’s degree in Engineering, Quality, Manufacturing or related discipline

Tools

Minitab

Job description

Freudenberg Medical Ireland Ltd. is seeking a Quality Manager to lead quality assurance in a highly regulated medical device manufacturing environment. You will own CAPA, audits, change control and supplier quality to ensure compliance and product safety.

We value hands-on leadership, Lean Six Sigma, data-driven decision making and strong collaboration with customers, suppliers and regulators to drive practical improvements.