Principal Service Development Quality Engineer

4 days ago


Arden Hills, Minnesota, United States myGwork Full time
Job Title: Principal Service Development Quality Engineer

At myGwork, we're committed to fostering a culture of diversity, innovation, and collaboration. As a Principal Service Development Quality Engineer, you'll play a critical role in ensuring the highest quality products are delivered to our customers.

Key Responsibilities:
  • Reduce and control service process nonconformances by leading efforts/teams focused on identifying primary root causes and implementing corrective and preventative actions.
  • Develop and implement service quality plans, documents, and systems by supporting the creation of service plans, product-specific service processes, and service risk analysis in conjunction with other product development team members.
  • Develop and implement product performance monitoring by identifying critical service processes and devising methods to reduce nonconformances in order to reduce/eliminate issues impacting product reliability.
  • Collect and analyze field product performance by systematically gathering quality metric data and performing the appropriate analysis method(s) to enhance service processes, sustaining product design, and new product development.
  • Create Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams.
  • Evaluate the adequacy and compliance of systems, operations, and practices against regulation and company documentation.
  • Actively participate and partner in Global Installation and Servicing community of practice to identify opportunities and drive improvements.
Requirements:
  • BS in Industrial, Biomedical, Mechanical, Electrical Engineering, or related degree.
  • Minimum of 7 years of medical device engineering experience.
  • In-depth familiarity with the FDA, ISO, MDD, EU MDR, and the medical device industry quality requirements.
  • Solid technical writing skills.


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