Quality Engineer II

US-CA-Rancho Santa Margarita


As a Quality Engineer II, you will use your skills to support medical device quality through design controls, process validations and documentation as part of a cross-functional team.


  • Conduct experiments to prove hypotheses

  • Create and validate test methods for design verification and manufacturing inspection testing by using measurement system analysis, gauge R&R and other relevant techniques

  • Implement statistical techniques to determine sample sizes and levels of confidence

  • Implement statistical process controls to monitor validated processes

  • Design engineering test protocols and use a data-driven approach to collect, analyze and summarize data into engineering reports

  • Perform root cause investigations for design and manufacturing

  • Document Non-Conformance Investigations (NCIR)

  • Document and implement Corrective and Preventative Actions (CAPA)

  • Generate protocols and reports for Installation, Operational and Performance Qualification (IQ, OQ, PQ)

  • Review engineering documents to ensure quality and compliance

  • Collaborate with design and manufacturing teams to assess device risk profile and failure modes in design (dFMEA) and manufacturing (pFMEA)

Position Requirements


  • 1-2 years of relevant work experience

  • Bachelor’s degree in an Engineering or STEM field or related education and experience

  • Experience in process verification and validation procedures

  • Exposure to ISO 9001 and ISO 13485

  • Exposure to CFR 21

  • Exposure to FMEA

  • Understanding of manufacturing, quality and risk management standards

  • Effective oral and written communication skills

  • Excellent technical writing

  • Ability to work effectively in cross-functional teams

  • Ability to read, analyze and interpret complex documents


Preferred Qualifications

  • Experience in the medical device industry

  • Working knowledge of statistics as it applies to verification testing and process control, and previous use of statistical analysis software, such as Minitab

  • Experience with project management tools (i.e. Microsoft Project)

  • Experience with software such as NetWeaver/Product Lifecycle Management

  • Experience with leading a team or project


Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed

Need help finding the right position?

We can recommend positions specifically for you! Click here to get started.