Quality Engineer III

US-CA-Rancho Santa Margarita

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Applied-Medical-Logo-w-Tag_H_Teal_cropped

 

Quality Engineer III

 

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 Quality Engineer III, 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

  • 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

  • 3-5 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
  • Experience with ISO 9001 and ISO 13485
  • Experience with CFR 21
  • Experience with 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

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

Benefits

  • 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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