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Quality Assurance Manager Medical Devices

Antal International
Job LocationNewcastle Upon Tyne
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Our client is a leading Medical device organisation who is presenlty for a QA Manager to join their expanding team at their site in North East England.As this role will be responsibilities for elements of the site quality management system they are looking for an experienced, professional profile. Responsibilities will include the management of Quality Systems, Design Quality and Supplier Quality. The QA Manager is experienced in multiple areas of medical device quality assurance and can apply that experience and in-depth knowledge. Serves as a resource for colleagues with less experience. May lead projects with manageable risks and resource requirements. Ability to tackle sophisticated problems affecting the quality system. May serve as representative on task forces, councils or improvement initiatives.In this role you’ll

  • Supervisory responsibilities for four QA professionals covering Design Quality, Supplier Quality and Quality Management. Set priorities and coordinates resources to meet priorities.
  • Responsible for planning, coordinating and conducting duties related to the Quality Systems, Supplier Quality and Design Quality
  • Utilize knowledge and experience to identify, tackle and document problems and risks within the quality system.
  • Serve as a resource and mentor to colleagues with less experience, including QA Officers.
  • Use company Business System tools on a regular basis to continually improve the QA function.
  • Work closely with QRA management in developing quality objectives.
  • Establish and maintain positive relationships with internal and external partners.
  • Maintain solid understanding of relevant regulations and quality system requirements that affect the business.
  • Other duties as assigned by management.
    • What you’ll need to do the job
  • Degree in science, medical or technical field and experience with growing responsibility in medical device Quality Assurance.
  • Quality management experience with medical devices or pharmaceuticals.
  • Ability to manage and develop a small team of quality management professionals
  • IVD medical device regulatory affairs experience a distinct advantage
  • Experience in conducting and hosting quality system audits/regulatory inspections. Experience with the MDSAP programme.
  • Solid understanding of international IVD medical device quality systems including but not limited to 21 CFR 820 and ISO 13485.
  • Experience in IVD medical device NPD, design controls and risk management
  • Experience in supplier quality, IVD reagent manufacturing, design transfer processes
    • Required skills
  • ISO
  • Medical Devices
  • Quality Assurance
  • Quality Management
  • IVD

    • Keyskills :
    ISO Medical Devices Quality Assurance Quality Management IVD

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