Quality Engineer

4 weeks ago


Boston, United States Connect Life Science Full time

Position: Quality Engineer

Location: Boston – Hybrid (25% onsite)

Duration: 6 Months Contract


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


Job Responsibilities:

  • Initiate medical device quality assurance activities in accordance with (FDA 21 CFR 820, ISO 13485; and other applicable regulatory requirements).
  • Support device complaint investigation and failure analysis.
  • Participate in design and drawing reviews to ensure that components meet requirements for design and patient safety requirements.
  • Interface and take the lead QA role in interactions with suppliers, contractors, and consultants supplying components, subassemblies, and contract processing.
  • Lead complaint investigations on returned product.
  • Manage corrective action and quality improvement activities.
  • Lead in technical discussions with suppliers to identify and implement improvements in products and processes.


Experience:


  • Bachelor's Degree in Engineering or technical field with minimum 5-7 years
  • Experience supporting, coordinating and / or leading projects
  • Experience in development of new or existing medical devices
  • Knowledge of regulatory Medical Device regulations (FDA 21 CFR 820, ISO 13485; and other applicable regulatory requirements).
  • Investigation and root cause analysis skills
  • knowledge of change control process and project management



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