Quality Engineering Leader: Process Excellence & Compliance

4220 embecta Penel Irish Branch; Dún Laoghaire; On-site; EUR 70,000 - 90,000; Full time

Job summary

The 4220 embecta Penel Irish Branch is seeking an experienced Quality Engineering Manager for its Dun Laoghaire site. This vital role involves leading quality management efforts, ensuring compliance with ISO standards, and driving continuous improvement initiatives.

You will oversee process validation, support cross-functional teams, and provide leadership within the Quality Engineering function. Candidates should possess a relevant qualification and extensive experience in regulated environments, ideally within medical devices. The role emphasizes collaboration, process optimization, and technical documentation.

Qualifications

• Minimum of 5 years’ experience in a regulated ISO 9001 / ISO 13485 environment.
• At least 3 years’ experience in a supervisory or people management role.
• Knowledge of Statistical Process Control and Six Sigma methodologies.

Responsibilities

• Lead process validation activities and review validation studies.
• Manage core quality systems supporting production and compliance.
• Drive improvements across Quality Assurance and Quality Control systems.

Skills

Quality Assurance

Process Validation

Statistical Process Control

Leadership

Communication Skills

Education

Third-level qualification in Engineering or Science

Tools

ISO 9001

ISO 13485

FDA Regulations

Six Sigma

Job description

The 4220 embecta Penel Irish Branch is seeking an experienced Quality Engineering Manager for its Dun Laoghaire site. This vital role involves leading quality management efforts, ensuring compliance with ISO standards, and driving continuous improvement initiatives.

You will oversee process validation, support cross-functional teams, and provide leadership within the Quality Engineering function. Candidates should possess a relevant qualification and extensive experience in regulated environments, ideally within medical devices. The role emphasizes collaboration, process optimization, and technical documentation.