Quality Engineering Manager

embecta; Leinster; On-site; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Purpose-Driven Work

Collaborative Environment

Career Growth

Commitment to Excellence

Job summary

A global medical devices company in Dun Laoghaire is seeking a Quality Operations Manager to ensure quality compliance and drive improvements. This role involves leading the Quality Engineering Team, aligning quality systems with ISO standards, and managing CAPA processes. The ideal candidate has a qualification in Engineering or Science, 5+ years in relevant ISO environments, and leadership experience. Emphasis on quality assurance and operational excellence is crucial, along with a collaborative spirit and strong analytical skills.

Qualifications

• Minimum 5 years in ISO 9001/2000 or ISO 13485 environment.
• At least 3 years of supervisory experience.
• Familiarity with FDA requirements and managing FDA audits.

Responsibilities

• Lead and develop the Quality Engineering Team.
• Ensure quality systems align with ISO standards.
• Drive continuous improvement initiatives with production teams.
• Manage CAPAs, maintain documentation, and prepare for audits.

Skills

Team development

Problem-solving

Analytical skills

Interpersonal communication

Statistical Process Control

Six Sigma methodologies

Education

Third-level qualification in Engineering or Science

Postgraduate qualification (plus)

Job description

embecta is a global diabetes care company that leverages its 100‑year legacy in insulin delivery to empower people with diabetes.

Our team values your contributions and offers competitive pay, benefits, continuous learning and career growth.

Are you a passionate quality professional ready to lead and drive excellence? embecta is seeking a Quality Operations Manager to join our Dun Laoghaire team. This critical leadership role will maintain the highest standards of quality, compliance and continuous improvement.

Responsibilities

• Be a key member of the Dun Laoghaire Quality Leadership Team and the site’s extended leadership team, and lead and develop the Quality Engineering Team.
• Ensure our quality systems align with ISO standards and meet all embecta and external regulatory requirements.
• Partner with production teams to drive continuous improvement initiatives.
• Manage key quality system elements, including non‑conformance processes, incident reporting and customer complaint analysis.
• Ensure timely and compliant completion of CAPAs, maintain high‑quality documentation and prepare confidently for audits.
• Oversee the activities of the Quality Control group.
• Lead key improvements in quality assurance and control systems, championing innovation and operational excellence.
• Build strong relationships with external customers.
• Provide oversight and ensure GMP standards are consistently met in production and quality engineering activities.

Education and Experience

• Third‑level qualification in Engineering or a Science discipline is required; a postgraduate qualification in a related area is a plus.
• 5+ years in an ISO 9001/2000 or ISO 13485 environment, ideally in Medical Devices or the Pharmaceutical industry.
• At least 3 years of supervisory experience with a proven track record of team development.
• Experience preparing technical documentation and managing CAPA systems.
• Familiarity with Statistical Process Control and Six Sigma methodologies (Greenbelt Certification is a bonus).
• Knowledge of FDA requirements and experience managing FDA audits.
• Experience with process validation, sterilization and clean‑room environments is advantageous.
• Strong interpersonal and communication abilities.
• Exceptional problem‑solving and analytical skills.
• Ability to work effectively in cross‑functional teams through collaboration.
• Proficiency in standard business software and systems.

Benefits

• Purpose‑Driven Work: Make a tangible impact on the quality and safety of medical devices that improve lives.
• Collaborative Environment: Work alongside passionate professionals in a culture that values teamwork and innovation.
• Career Growth: Take your career to the next level with opportunities for professional development and leadership.
• Commitment to Excellence: Be part of a company that is dedicated to upholding the highest standards in everything we do.

embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.