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Quality Control Manager – Medical Device

Avery Dennison · Longford

Hybrid Senior 🇬🇧 English
ISO 13485 21 CFR Part 820 cGMP regulatory compliance

Job description

About the role

The Quality Control Manager will lead the quality function for a world‑class medical device contract manufacturer. You will direct quality engineers and inspectors, collaborate with engineering, manufacturing and service teams, and ensure that raw materials, work‑in‑process and finished products meet stringent standards.

Key responsibilities

  • Formulate and execute a strategy that drives a high‑performance, "right first time" quality culture.
  • Coach, develop and manage the quality staff throughout the manufacturing process.
  • Lead continuous improvements to the quality system to maintain suitability, adequacy and effectiveness.
  • Ensure compliance with cGMP, ISO 13485 and FDA 21 CFR Part 820 regulations.
  • Work closely with commercial and operations teams to add value for key accounts and collaborate with customer quality representatives on innovation and improvement plans.
  • Provide direction for quality engineers and inspectors and establish quality standards for raw materials, WIP and finished goods.

Required profile

  • Bachelor’s degree in Engineering or a related scientific field.
  • Minimum 4 years 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.
  • Strong written, verbal and presentation skills with the ability to work across functions and organizational levels.

Required skills

  • Thorough knowledge of ISO 13485.
  • Understanding of FDA 21 CFR Part 820.
  • Familiarity with cGMP requirements.
  • Experience with quality management systems and regulatory compliance.

What we offer

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

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Published 2 months ago

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Avery Dennison

Longford