Senior Principal Quality Engineer MASSACHUSETTS

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Senior Principal Quality Engineer MASSACHUSETTS

At GxPeople Global, we're in search of a Quality focused Medical Device expert with a proven track record and exceptional interpersonal skills to take on the role of Senior Principal Engineer, Quality. Join our esteemed medical device client, where you'll be instrumental in advancing quality operations and shaping the forefront of innovative medical technologies globally.

 

Senior Principal Engineer, Quality

 

Job Summary

The Senior Principal Engineer, Quality supports the product development process to review specifications, develop product test methods and equipment, lead the verification and validation program for hardware and disposable administration sets, conduct supplier qualification and management activities and support design transfer to manufacturing. This key role also aids in the manufacturing process by overseeing IQ, OQ, and PQ for both manufacturing tools and processes, which involves determining appropriate sample sizes for these tools.

 

Responsibilities

  • Evaluate design specifications for clarity and testability.
  • Actively participate in design reviews for new products.
  • Lead and facilitate design verification and validation activities for both hardware and disposable sets.
  • Establish quality plans for new products.
  • Manage and facilitate IQ, OQ, and PQ processes for manufacturing tools.
  • Facilitate pre- and post-market risk management activities.
  • Lead the development of production test methods, equipment, and process validation activities.
  • Oversee the supplier management process, conducting audits and addressing corrective actions.
  • Maintain records to ensure regulatory compliance

 

Requirements

  • Bachelor’s degree in Engineering or a related field.
  • Over 6 years of relevant experience in the medical device industry.
  • Familiarity with FDA regulations, particularly in the context of medical device products.
  • Experience in compliance with Good Manufacturing Practices (GMPs).
  • Demonstrated excellence in leadership and communication skills.
  • Ability to operate independently with sound judgment.
  • Capability to mentor junior staff.

 

**Please not this role is only open to candidates who are eligible to live and work in the USA**

 


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