Senior Design Quality Assurance Engineer

22 hours ago


Portland, Oregon, United States Riverpoint Medical Full time
Job Title: Senior Design Quality Engineer

Riverpoint Medical, a leading manufacturer of premium medical devices, is seeking a highly skilled Senior Design Quality Engineer to join our team in Northeast Portland.

About the Role:

The Senior Design Quality Engineer will be responsible for ensuring the design, development, and manufacturing of our medical devices meet the highest quality standards and regulatory requirements. This includes:

  • Developing and implementing quality assurance processes and procedures
  • Conducting technical product/design validation/verification studies and evaluations
  • Leading activities to ensure reliability and quality of the design and manufacturability of the product
  • Supporting ongoing global regulatory compliance, including submissions and audits
  • Recommending design or test methods and statistical process control procedures
  • Completing hazards and risk analysis studies of design and processes
  • Compiling and analyzing complaints, performance reports, and process control statistics
  • Driving CAPA and Nonconformance investigations and ensuring corrective measures meet acceptable standards
Requirements:

To be successful in this role, you will need:

  • Bachelor's Degree in Engineering or a related field
  • Experience in design assurance or design quality in new product development in an FDA-regulated environment
  • Knowledge of cGMP, QSR, ISO 13485, MDSAP, and MDR
  • Strong technical writing skills and ability to communicate effectively
  • Computer skills, including Word and Excel
What We Offer:

Riverpoint Medical offers a competitive salary and benefits package, including medical, dental, and vision insurance, 401(k) with company match, and paid time off. We also offer bonus pay and opportunities for professional growth and development.

We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and experienced quality engineer looking for a new challenge, please submit your application.



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