Quality Control Manager

About the role

You will lead the quality function, directing quality engineers and inspectors while collaborating with engineering, manufacturing, and service teams to set quality standards for raw materials, work‑in‑process, and finished products.

Key responsibilities

• Formulate a strategy to foster a high‑performance, "right first time" quality culture for a world‑class medical device contract and legal manufacturer.
• Drive continuous improvements to the quality system to ensure its suitability, adequacy, and effectiveness.
• Ensure compliance with cGMP, ISO 13485, and FDA 21 CFR Part 820 regulations.
• Partner with commercial and operations teams to add value for top key accounts and engage directly with customer quality representatives.
• Provide QA support for the review and approval of plant validation protocols, reports, and change requests.

Required profile

• Bachelor’s degree in Engineering or a scientific discipline.
• Minimum 4 years of experience in the medical device or pharmaceutical industry, including at least 3 years in regulatory compliance and quality systems.
• At least 4 years of experience managing a team.
• Thorough knowledge of ISO 13485 and FDA 21 CFR Part 820.
• Professional certifications such as CQE, CQA, or CMQ/OE are preferred.

Required skills

• cGMP
• ISO 13485
• FDA 21 CFR Part 820
• Quality Management Systems
• Validation protocol development and review

What we offer

• Financial & health benefits including healthcare allowance, insurance, pension, service awards, and gift vouchers.
• Generous leave (up to 25 days after 10 years) and flexible working arrangements.
• Continuous development through company trainings, educational assistance, and individual development discussions.
• Well‑being support via an Employee Assistance Programme, mental‑health webinars, IBEC Keep Well accreditation, free onsite parking with electric‑car charging, and a cycle scheme.