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Site Quality Manager- Medical Device

Site Quality Manager- Medical Device

Site Quality Manager- Medical Device Manufacturing

Ready for a move into your next role as a Quality Manager? Are you interested in growing your career in a Start-Up Medical Device manufacturing organisation? Maybe this is the perfect role for you.

Our client, a leading Medical Device manufacturer based in the Midlands are looking to grow their existing team with an enthusiastic and experienced Quality Manager. This is a permanent position that will offer excellent career development opportunities for the right individual. The successful candidate will have full responsibility for managing all of the Quality requirements for the site and will ultimately develop and lead the Quality team on site once the company have moved past start up phase. 

What you will do in this job:

  • Responsible for developing and implementing the QMS system for the site
  • Responsible for ensuring product and facility compliance to ISO 9001, ISO 13485 and FDA
  • Manage approval process and be the main point of contact with governing bodies
  • Work with senior leaders in other departments to ensure alliance to quality and manufacturing standards
  • Lead and take part in Continuous Improvement activities on site
  • Plan and manage departmental budget
  • Lead and develop newly formed Quality Team 
  • CAPA process management

Minimum requirements for this job: 

  • Level 8 Degree in Science, Engineering or related field
  • 3+ years management experience required
  • Experience developing and implementing robust QMS systems
  • Strong knowledge of ISO 9001 & 13485, FDA regulations, Class I and Class II Medical Devices
  • Knowledge of CE certification process
  • Lean Six Sigma qualification desireable
  • Excellent decision-making skills, strong leadership and communication proficiency

The Next Step for you:

Interested in this role? Please send your CV to Kate Curran at Next Generation Recruitment by clicking on the Apply button!

Next Generation specialise in Life Science, Engineering, Supply Chain & Operations, Data Science, Digital Marketing, and IT.

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