Quality Engineer II

Applied Medical Distribution Corporation Rancho Santa Margarita , CA 92688

Posted 2 months ago


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 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

  • 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

  • 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

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 vacation accrual and paid holiday schedule

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