Quality Assurance Manager

2 weeks ago


Boston, United States Connect Life Science Full time

Position: Contract Quality Manager

Location: Boston Hybrid

Duration: 12 Months Contract

A medical device manufacturer, bringing a device to the market are seeking a Quality Manager who is a critical thinker, data driven, and quality minded.

Job Responsibilities:

  • plan, direct and control the companys quality system
  • with the project management team
  • medical device quality assurance activities in accordance with (FDA 21 CFR 820, ISO 13485; and other applicable regulatory requirements).
  • device complaint investigation and failure analysis.
  • corrective action and quality improvement activities.
  • Lead in technical discussions with suppliers to identify and implement improvements in products and processes.

Experience:

  • Degree in Engineering or technical field
  • in Medical Device
  • in leading projects
  • in development of new or existing medical devices
  • of regulatory Medical Device regulations (FDA 21 CFR 820, ISO 13485; and other applicable regulatory requirements).
  • of change control process and project management

Interviews taking place week commencing 15th April, please apply early to discuss this position.



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