Quality Systems Manager - Medical Devices

Posted 08 July 2024
Salary Negotiable
LocationMassachusetts
Job type Full Time
Discipline Medical Devices
ReferenceBBBH1805_1720454355
Contact NameSiobhan Mcloughlin

Job description

Mantell Associates are thrilled to have partnered with one of the most technologically advanced, game changing Medical Device companies who have completely transformed the world of imaging. Due to significant growth projects for the business they are looking for a Quality Systems Manager to join their high performing Quality team.


Quality Systems Manager - Responsibilities:

  • Have responsibility for the compliance and upkeep of the QMS
  • Ensure all regulatory requirements are in line with both internal and external oversight from FDA, ISO, MDD/MDR etc
  • Manage Document Control system, including the Change Order process.
  • Manage the CAPA, Complaints, SCAR, and Audit Findings processes.
  • Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS.
  • Have oversight over supplier management and internal supplier selection
  • Day to day management of 2 in the Quality team


Quality Systems Manager - Requirements:

  • 4 - 5 years' experience in a Quality function ideally within a Medical Device company or similarly regulated environment
  • Knowledge and ability to maintain and improve a Quality Management System
  • Experience with external and internal audits is highly desirable
  • Either experience in, or a desire to be a people manager (this role can be a step up for someone looking to move into a more managerial position)

This is a hybrid position requiring 3 days onsite per week just outside Cambridge, MA. Unfortunately this position is not open to those requiring visa / sponsorship support at this time so please ensure you have a valid work visa before applying.

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this role, contact us at +44 (0)20 3854 7700.