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Quality Systems Manager

  • Location

    Cambridge

  • Salary

    Negotiable

  • Sector

    Compliance

  • Job Ref

    88787

  • Contact

    Will Godfrey

  • Published

    18 Tage her

Übersicht

A fantastic opportunity for a Quality Systems Manager to join our medical device client who design, develop and manufacture medical devices. The role will be based in Cambridge but offers a mix of flexible working, and will suit someone who has experience of Medical Devices going from early phase/new concept development to clinical trial ready products and will be the Quality Lead on site.

Benefits

  • Hybrid working

  • Pension scheme (8% employer contribution, 3% employee)

  • 28 Days annual leave (plus bank holidays)

  • Medical/Dental/Health Insurance

  • Bonus

  • Relocation offered

Responsibilities

  • Managing/Improving the ISO13485 QMS

  • Manage and Conduct Internal and External Audits

  • Providing Quality Training and Development to the Team

  • Being the Site SME for Quality

  • To develop / maintain relevant legislative, compliance, and regulatory knowledge

  • Producing/delivering accurate & reliable reports and presentations of regulatory data

Required Skills

  • Experience of working within an ISO 13485 quality system for the design and development of medical devices

  • Working knowledge and experience of compliance with the Medical Devices Directive and US FDA 21 CFR.

  • Experience of facilitating and supporting internal and external quality system audits.

For immediate consideration please forward your most up to date CV.

If you would like to find out more about this role or similar med tech jobs, please get in touch with our tech recruiters at Austin Vita.