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Quality Manager FTC

  • Location


  • Salary

    Up to £49500.00 per annum

  • Sector


  • Job Ref


  • Contact

    Cece Ekemezuma

  • Published

    27 days ago


Industry: Medical Devices

Role: 12 Month FTC - QA Manager

Location: Cumbernauld, Scotland (Hybrid)

The Company

Our medical device manufacturing client , based in Cumbernauld is looking to welcome a QA Manager on to the team!

We are really excited to bring this opportunity to you as we search for the perfect fit for an organisation that has A LOT to offer!

The Role

Our client is looking for an experienced QM to take responsibility for the organisations QMS for it's GLOBAL products! This QM needs to ensure the correct emphasis is placed on the safety and effectiveness of these products (including class iii medical devices) whilst also providing measured and objective support throughout the organisation in accordance with the quality framework of the business.

Key Responsibilities include:

  • Design, development, continuous improvement and maintenance of the QMS (Quality Management System) in accordance with all relevant certification standards.
  • Overall management of change control and document control systems.
  • Overall management of customer complaints and warranty program.
  • Overall management of supplier approval and monitoring.
  • Overall management of company internal audit process.
  • Leadership of the UK Cumbernauld site Quality team.
  • Responsible for managing the UK Cumbernauld site Quality team (performance monitoring, coaching and development of employees).
  • To delegate authority where necessary in a clear manner and ensure that delegated personnel fully understand their responsibilities.
  • To have full authority and responsibility to act on behalf of the company in all matters related to product quality and to execute that authority to the satisfaction of customers and Regulatory authorities.
  • To have executive responsibility for directing and controlling the organisation regarding all quality issues.
  • To have the authority to establish and make changes to the Quality Policy and QMS.
  • Act as Management representative for the company's Quality System.
  • Act as Person Responsible for Regulatory Compliance with respect to core Quality obligations and responsibilities.
  • Responsible for working in cross-functional teams as the UK Quality voice.

What we need from you:

  • Qualified to degree level in a relevant discipline.
  • 5 years' experience working in a medical devices company in a QA position.
  • Experience and knowledge of ISO 13485 rev 2016 and the European Medical Device Regulations (MDR).
  • Working knowledge of global certification requirements.
  • Experience in working with quality aspects of medical devices and GMP.
  • Working knowledge of process validation requirements in a life sciences discipline.
  • Working knowledge of NPD and NPI in a life sciences discipline.
  • Excellent communication skills.
  • Competent IT skills across Microsoft suite of programs.
  • Excellent project management skills.
  • A working knowledge/awareness of Lean Six Sigma principles and techniques would be advantageous.

How to apply

If you're interested in hearing more, reach out TODAY!

Austin Fraser is acting as an Employment Agency in relation to this vacancy.

Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.