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Senior Quality Systems Manager

  • Location

    Newton, United Kingdom

  • Sector:

    Quality & Validation

  • Job type:

    Permanent

  • Salary:

    $115,000 - $140,000

  • Contact:

    Callum Sparkes

  • Contact email:

    callum.sparkes@catalystcareers.com

  • Job ref:

    58501

  • Published:

    2 months ago

  • Expiry date:

    2021-07-13

  • Consultant:

    Callum Sparkes

Catalyst Life Sciences have been engaged in the search of a Senior Quality Manager to join a fast growing Medical Devices organization commercializing their orthopaedic device used in treating musculoskeletal diseases that has recently received 510(k) clearance.

Essential Responsibilities:

  • Lead overall quality management system (QMS) execution to ensure compliance with cGMP, regulatory agencies, client and corporate expectations.
  • Work closely with Contract Manufacturing Organisations (CMOs) to ensure all suppliers on the ASL adhere to FDA and ISO13485 standards through regular contact and audits. 
  • Develop and maintain system for monitoring quality metrics, including post market surveillance activities.
  • Lead and supervise a small team of a Document Control Specialist and Quality Specialist.
  • Provide quality system performance reports to management and develop and maintain Customer Complaint System.
  • Work collaboratively with the VP Quality for the company's US operations, as well as cross functionality responsibilities with the global team.
  • Work autonomously with the entire QMS, being the point of contact for deviations, CAPA implementations, change controls, SOPS.  

Candidate Requirements:

  • Bachelor's in a Science, Engineering, or relevant field.
  • 8 years' experience in a Quality focused position in the Medical Devices industry under ISO:13485 and FDA guidelines.
  • Experience working with orthopaedic devices is a must.
  • Prior exposure to working in a start up / small company environment (<100 people)
  • Ability to work both autonomously and collaboratively in a small company environment.
  • US Citizen or Green Card holder.