Senior Quality Engineer

US-CA-Rancho Santa Margarita

Overview

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


 


Responsibilities


Provide guidance on and complete the following:



  • Contribute to the design, verification, and validation of new products

  • Design and manage new product development to ensure compliance throughout the product’s life cycle

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

  • Teach, guide and mentor other team members in your areas of expertise to help with technical development

Position Requirements

Requirements



  • 5+ years of relevant work experience, including work experience in an FDA regulated industry

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

  • Experience in process verification and validation procedures

  • Extensive knowledge of ISO 9001, ISO 13485, and CFR 21

  • Extensive experience with FMEA

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

  • 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

  • Quality Engineering Certification (CQE)

  • Certification with Six-Sigma, Design for Reliability and Manufacturability (DRM), or similar.

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

  • Experience with software such as Netweaver / Product Life-Cycle Management, SolidWorks or Minitab

  • Experience with leading teams or projects

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