Quality Engineer II

US-CA-Rancho Santa Margarita

Overview

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.


Responsibilities



  • 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

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

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