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Job Information

International QA Manager – Class III Medical Devices

Information About this Role

Job Summary

Job Title: International QA Manager – Class III Medical Devices

Salary: Highly competitive with full corporate benefits including pension, healthcare, subsidised canteen, on site gym & more!

Company Description

We’ve got an exciting opportunity as an International QA Manager – Class III Medical Devices for a renowned global leader in orthopaedic medical technology. Our client offer the widest range of advanced technologies giving you the chance to work & grow with the most cutting edge spinal products in the market.

Want a rewarding career? Our Client are a regular feature in Fortune Magazine’s 100 best companies to work for so you’ll be sure to get the best out of your workday & take your career to the next stage! They also offer a comprehensive corporate benefits package & lovely offices to ensure a quality job satisfaction.

Job Description for the International QA Manager – Class III Medical Devices:

The primary responsibility of the International QA Manager – Class III Medical Devices is to recruit, engage & retain the most qualified employees ensuring company performance is met or exceeded.

Duties and Responsibilities for the International QA Manager – Class III Medical Devices includes:

  • Recruiting & developing a strong team, managing performance & setting objectives
  • Proposing QA objectives for non RAQA staff & setting up QA objectives for current RAQA staff
  • Ensuring business operates in line with the Corporate QA System & ISO 13485 standard
  • Ensuring the team meet objectives by effective employee monitoring & staff development
  • Managing relationships with ISO 13485 certification delivery partners
  • Being accountable for company  compliance with ISO 13485 standard
  • Developing & maintaining a central EEMEA QMS & comprehensive documentation system
  • Managing the global EEMEA CAPA system
  • Ensuring processes in local countries are compliant with Corporate & EEMEA QMS,
  • Implementing Divisional Quality Audits for all processes
  • Training staff on processes that meet local regulatory requirements
  • Organising formal Management reviews of the Quality System & ensuring it’s suitability & effectiveness
  • Keeping senior management informed about Quality Management System performance
  • Ensuring training programs to support the QMS are defined & implemented
  • Ensuring  distributors are audited in line with company requirements
  • Understanding customer requirements & providing products & services that meet customers’ expectations

Experience and Skills Required for the International QA Manager – Class III Medical Devices

  • Understanding of a Quality Management environment such as EFQM, TQM
  • Previous involvement in an international medical device company & medical device regulation environment (3 years)
  • Previous experience in vigilance
  • Project Management experience
  • Open minded & able to build relationships with colleagues in different countries & cultures
  • Excellent written & verbal communication skills
  • An abstract & analytical thinker
  • Organisational expertise with the ability to juggle multiple tasks & meet deadlines
  • Ability to influence senior colleagues
  • Determined & reliable with high standards for success
  • Bachelor degree in a technical or scientific field
  • Certificate in EN ISO 9001/13485 (desirable)

Sound like you? Apply NOW! Don’t miss out on this career building opportunity as an International QA Manager – Class III Medical Devices Today!

If you have any further queries regarding this role please call Tim on: 0203 800 0502

Projectus Consulting

Projectus Consulting are a leading Medical Device Recruitment Consultancy. We‘re a niche business who provide a highly specialist service to both employers and candidates in the Medical Technology Spaces. 

We are dedicated to finding the right opportunity for you.