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Quality Control Director

Michael Page Sales
Job LocationSouth Yorkshire
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Create and own the Quality Control procedures and function for a new manufacturing site. A member of the senior leadership team responsible for developing and operating a successful safe business.Client DetailsA rapidly expanding technical medical devices company.Description

  • Create and manage metrics for Product quality, manufacturing quality and on market feedback for the product related to quality.
  • Manage quality operations across sites and operate between manufacturing, packaging and distribution.
  • Update QMS to include other global QMS requirements including WHO/CMDCAS as required based on product.
  • Manage Product localisation and complaint release of products to the market
  • Train the wider organisation in the importance of product quality
  • Work with other group organisations to align on Quality for the business
  • Support external audits for global certification purposes.
  • Manage risk and validation activities for facility and processes, may include R&D sites.
  • Manage the compliance of final product release.
  • Manage complaints and PMS process
  • Manage the QMS processes and infrastructure to ensure continued compliance and fitness for purpose for the business.
    • ProfileKnowledge and experience of working to the appropriate quality and regulatory standards including ISO13485, FDA 21CFR Part 820Experience of managing and hosting competent authority, notified body and customer audits.Experience of working in an IVD or medical device environment or similar with minimum 5 years experience at Quality Manager level.Previous experience of managing product release of medical device/IVD products.Previous experience of aligning global company quality requirements and implementing resulting systemsExperience of managing and developing a high performing teamExperience of manufacturing and post launch IVD or medical device activitiesScientific background, minimum degree in Biology or Chemistry.Job OfferCompetitive remuneration package and a highly challenging visible senior management level role in a rapidly growing organisation. Required skills
  • Medical Devices
  • ISO13485
  • FDA 21CFR Part 820
  • Quality Director

    • Keyskills :
    Medical Devices ISO13485 FDA 21CFR Part 820 Quality Direct

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