Principal Quality Engineer

6 days ago


Irvine, California, United States Medtronic Full time
About the Role

We are seeking a highly skilled Principal Quality Engineer to join our team at Medtronic. As a key member of our Operations Quality OC Campus, you will be responsible for ensuring the highest quality standards in our manufacturing processes.

Key Responsibilities
  • Develop and implement quality standards and protocols for processing materials into partially finished or finished products.
  • Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
  • Design and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
  • Conduct quality assurance tests and perform statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
  • Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
Requirements
  • Baccalaureate degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
  • Strong experience supporting Receiving Inspection and Manufacturing Line Support (Operations Quality).
  • Strong experience in Supplier Quality.
  • Experience leading/mentoring teams of engineers and/or inspectors.
  • Strong Knowledge developing and implementing Test Methods, as well as TMVs.
  • Lean Six Sigma/DRM Knowledge.
  • Strong process improvement mindset.
  • QAD ERP Experience.
  • Tier Management Experience.
  • Knowledge using and implementing various Vision Systems for inspection, preferably Keyence.
  • Working knowledge of Quality System Regulation (QSR 21 CFR 820).
  • Understanding of Risk Management in accordance with ISO 14971.
  • Strong knowledge of ISO 13485 requirements.
What We Offer

Medtronic offers a competitive salary and flexible benefits package. We are committed to our employees' lives and recognize their contributions. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S. (excl. PR) locations (USD): $116,000 - $174,000.

The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location.



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