Senior Quality Engineering Lead — Medical Devices

Edwards Lifesciences; Limerick; On-site; EUR 90,000 - 120,000; Full time

Job summary

Edwards Lifesciences in Ireland (Limerick) seeks a Quality Assurance Manager to lead site quality system operations, including QA for in-process and finished goods, inspections, and release documentation.

You will drive CAPA programs, audits, and regulatory compliance across GMP manufacturing, mentoring teams, and collaborating with cross-functional groups to sustain a culture of quality and continuous improvement.

Qualifications

• Bachelor’s degree in science or engineering is required.
• Experience managing audits by regulatory agencies for class II/III medical devices or equivalent.
• Proven people management experience.
• Experience in a regulated manufacturing environment.

Responsibilities

• Lead quality assurance for in-process and finished goods.
• Oversee site quality system, audits, and final release documentation.
• Drive CAPA program and continuous improvement.
• Collaborate with cross-functional groups to resolve quality issues.
• Provide technical guidance on quality engineering practices.

Skills

People management

Project management

Quality systems

Regulatory compliance

Lean Six Sigma

Education

Bachelor’s Degree in Science or Engineering

Tools

Microsoft Excel

Quality management software

Job description

Edwards Lifesciences in Ireland (Limerick) seeks a Quality Assurance Manager to lead site quality system operations, including QA for in-process and finished goods, inspections, and release documentation.

You will drive CAPA programs, audits, and regulatory compliance across GMP manufacturing, mentoring teams, and collaborating with cross-functional groups to sustain a culture of quality and continuous improvement.