Quality Assurance Manager, Medical Device

Are you a Quality Assurance professional looking for a career developing opportunity?

Do you have a Medical Devices background and have good knowledge of MDR?

Do you want to build a QA department and be a Quality Assurance leader?

Fraser Dove International is working exclusively with an established, Medical Devices organisation seeking an ambitious leader to lead the MDR transition and be develop a QA Medical Devices team.

Discover more about our Quality Assurance Manager opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.

Your objectives:

As the Quality Assurance Manager, you will be measured against the following objectives:

1) Lead the MDR transition
2) Develop and execute the strategic plan for the Medical Devices Quality team
3) Be the EMEA QA Medical Devices expert

What you will do:

As the Quality Assurance Manager, your duties and responsibilities will include:

  • Be the subject matter expert on Medical Device Regulation/ISO 13485. Maintain medical device quality awareness in EMEA in relevant functions, follow MDR/ISO developments closely and develop and maintain Quality Management System
  • Responsible for Medical Device QA activities together with SAS Medical Device team
  • Plan the Medical Device QA strategy in EMEA together with Head of EMEA Quality Compliance
  • Ensure that a quality management system related to medical device is implemented and maintained in EMEA
  • Compile and update the medical device SOPs
  • Plan and execute the Medical Device QA strategy and organization in EMEA
  • Be the EMEA QA representative in Global Medical Device workshops
  • Compile and maintain the Quality Agreements related to Medical Device
  • Perform the operational quality tasks related to Importer and Distributor roles
  • Support and conduct internal and external MDR/ISO audits
  • Participate and support EMEA affiliates with Notified Body or any other regulative inspections related to Medical Devices/ISO
  • Perform internal Medical Device training
  • Coordinate and promptly perform any recall operations for Medicinal Devices together with Legal manufacturers
  • Handle the Medical Device complaints

What you will bring:

These are the skills and experience you will need to succeed as the Quality Assurance Manager:

  • 3+ years’ experience within Medical Device, Quality Assurance
  • GMP/GDP Regulations
  • Strong understanding of MDR and ISO regulation
  • Strong English verbal and written
  • Bachelor’s or Master’s degree in life sciences

What you will get:

These are the perks and benefits that will complement your generous base salary:

  • Bonus
  • Pension
  • Further package
Got what it takes?

To apply for the Quality Assurance Manager, click the ‘Apply’ button below or contact the Executive Search Consultant – Jason Cachia – on +44 (0)203 355 7050.

Please Note:
  • This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.
  • If you have not heard from an Executive Search Consultant within ten working days from the date of your application, please consider yourself unsuccessful on this occasion.
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Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.