Quality Engineering Manager

2 months ago


Kearney, United States Catalyst Life Sciences Full time

Opportunity to join a global medical device manufacturer as Quality Engineering Manager.You'll be responsible for overseeing a small team of quaility & validation engineers through manufacturing, labelling & packaging change initiatives.


Responsibilities

  • Manage the quality engineering processes, including risk management, design control, process validation, and change control.
  • Ensure compliance with FDA regulations, ISO standards, and other relevant regulatory requirements.
  • Collaborate with cross-functional teams including R&D, manufacturing, and regulatory affairs to establish and maintain quality standards.

Experience Required

  • 6 years' Quality Engineering experience with knowledge of the Medical Devices and FDA, ISO:13485.
  • 3 years' management experience, performing day-to-day management responsibilities and perfromance reviews.

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