Product Quality Engineer

Position Location US-CA-Rancho Santa Margarita




Applied Medical is a rapidly growing, global organization that develops, manufactures and distributes medical devices to more than 75 countries. Our driving purpose is to satisfy the three fundamental healthcare needs: enhanced clinical outcomes, outstanding value and unrestricted choice. For 30 years, Applied Medical has been at the forefront of innovation and technology. As a result of our highly vertically integrated business model, we control all of our processes in-house, from R&D concept to clinical implementation. Applied Medical engineers take a hands-on approach, utilizing in-house cutting-edge technologies, such as automation and robotics, advanced metal processing, injection molding, and rapid prototyping. We invest heavily in R&D, advanced technologies and most importantly – the growth of our team members.                                                                                

Applied Medical is proud to have a culture firmly grounded in teamwork, collaboration and regulatory compliance, while providing opportunities for growth and choice in individual career paths.

Position Description

As a Product Quality Engineer, you will be responsible for working within the framework of a team and performing the following activities:


  • Evaluate the performance of products returned by the customer
  • Perform device analysis in accordance with model-specific procedures and protocols
  • Perform root cause analysis to investigate alleged product deficiencies
  • Propose corrective/preventive actions as required
  • Compose detailed reports describing results from investigations
  • Complete evaluations in a timely and accurate manner

Position Requirements

This position requires the following skills and attributes:

  • Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or similar engineering discipline
  • Minimum of 1 year of experience in the medical device field or other regulated industry
  • Effective problem solving and troubleshooting skills
  •  Proficient computer skills, including knowledge of spreadsheets and word processing
  • Possess excellent oral and written communication skills
  •  Able to work independently, in a team environment and cross-functionally with other departments
  • Able to learn quickly and be self-motivated
  • Strong multitasking and prioritization skills
  • Ability to respond to the urgent needs of the team with a proven track record of meeting deadlines


The following skills and attributes are preferred, but are not required:

  • Experience in conducting failure investigations, reliability testing and/or performing failure analysis leading to root cause and corrective/preventive actions
  • Working knowledge of FDA and ISO regulations
  • Working knowledge of manufacturing processes and equipment


  • Training and mentorship with ongoing learning and development courses
  • On-campus wellness activities
  • Comprehensive medical and dental coverage
  • Education reimbursement program
  • 401(k) program with employer match
  • Generous holiday and vacation accrual

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