Quality Engineer II - Medical Devices, CAPA & Audits

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

Job summary

Freudenberg Group's Freudenberg Medical Ireland Ltd. seeks a QA leader to ensure regulatory compliance and drive continuous improvement in quality systems across manufactured products.

You will lead audits, review inspection plans, collaborate with customers and suppliers, and mentor a small team, applying Lean and Six Sigma methodologies to reduce defects and support new product introductions.

Qualifications

• Degree / Diploma in Engineering, Science or Quality or related QA experience.
• Minimum 5 years in a similar QA role.
• 6 Sigma Green Belt or higher required.
• Lean principles knowledge; Lean Green Belt an advantage.

Responsibilities

• Identify and document customer requirements and implement in Freudenberg Medical manufacturing docs.
• Ensure Quality System complies with regulatory and customer requirements.
• Review and improve inspection plans for incoming, in-process and final products.
• Investigate quality issues and customer complaints using the CAPA system.
• Lead Quality Auditor activities and supplier quality audits; support customer/regulatory audits.
• Develop and update validation protocols, reports and test records as required.
• Supervise assigned staff and collaborate with customers and suppliers on quality issues.
• Participate in improvement activities and ensure OH&S and environmental goals are met.

Skills

Quality Assurance

People Management

Regulatory Knowledge

Problem Solving

Education

Degree / Diploma in Engineering, Science or Quality

Job description

Freudenberg Group's Freudenberg Medical Ireland Ltd. seeks a QA leader to ensure regulatory compliance and drive continuous improvement in quality systems across manufactured products.

You will lead audits, review inspection plans, collaborate with customers and suppliers, and mentor a small team, applying Lean and Six Sigma methodologies to reduce defects and support new product introductions.