Quality Engineer

4 weeks ago


Westford, United States Katalyst HealthCares & Life Sciences Full time
Responsibilities:
  • The purpose of this position is to initiate medical device quality assurance activities.
  • These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards.
  • This position will also support device complaint investigation and failure analysis as required.
  • Essential Duties and Responsibilities: Develop incoming inspection processes and document incoming inspection activities.
  • Provide in-process QA support to include inspection and document review.
  • Complete final acceptance activities.
  • Manage the sterilization process, including validations and product sterile loads.
  • Track nonconforming material and lead Material Review Board (MRB) efforts.
  • Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing.
  • Lead complaint investigations on returned product.
  • Manage corrective action and quality improvement activities.
  • Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc.
  • Assist in the performance of quality system internal auditing.
  • Support quarterly management review meetings. Establish, monitor and evaluate quality system metrics.

Requirements:

  • Bachelor's degree required, strongly prefer in Engineering
  • Minimum of 2 years of experience in manufacturing space working with suppliers/vendors.
  • Must be able to understand manufacturing so not looking for supplier "auditors . Must be "Technical who understand line manufacturing.
  • Process validation exp. With IQ, OQ and PQ a must
  • Must have a medical device background
  • Must be able to speak and work with suppliers/vendors.
  • Will be responsible for corrective action with suppliers/vendors
  • Process change management
  • Must have problem solving skills thru CAPA investigations.


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