Quality Operations Leader for Medical Devices & GMP

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

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.