Quality Engineering Manager - Med Devices

Edwards Lifesciences Gruppe; Limerick; On-site; EUR 90,000 - 130,000; Full time

Job summary

Edwards Lifesciences is seeking a QA/Quality Assurance leader to manage the site quality system, quality control, and assurance inspections for in-process and finished goods. You will oversee audits, final product release documentation, and CAPA programs while driving continuous improvement across cross-functional teams including Manufacturing, Supply Chain, and Engineering.

The role requires a Bachelor's degree in Science or Engineering, strong experience with regulatory inspections (FDA/ISO),

Qualifications

• Bachelor's Degree in Science or Engineering or equivalent.
• Experience leading internal audits and regulatory inspections (FDA, ISO, GMP).
• Proven people management and project leadership in a regulated environment.

Responsibilities

• Manage site quality system, quality control, and assurance inspections for in-process and finished goods.
• Oversee audits and final product release documentation.
• Lead CAPA programs, risk mitigation, and continuous improvement initiatives.
• Provide technical guidance across cross-functional groups (Manufacturing, Supply Chain, Engineering).
• Drive Six Sigma/Lean projects and design improvements to new products/processes.

Skills

Quality management

CAPA handling

Project leadership

Lean Six Sigma

Regulatory compliance

Audits & inspections

Cross-functional collaboration

Excel skills

Quality systems

Education

Bachelor's degree in Science/Engineering

Tools

Microsoft Excel

Quality systems software

Job description

Edwards Lifesciences is seeking a QA/Quality Assurance leader to manage the site quality system, quality control, and assurance inspections for in-process and finished goods. You will oversee audits, final product release documentation, and CAPA programs while driving continuous improvement across cross-functional teams including Manufacturing, Supply Chain, and Engineering.

The role requires a Bachelor's degree in Science or Engineering, strong experience with regulatory inspections (FDA/ISO),