Quality Engineer II

Company: Applied Medical Distribution Corporation
Location: Rancho Santa Margarita
Posted on: May 3, 2021

Job Description:

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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 and vision coverage
• Education reimbursement program
• 401(k) program with discretionary employer match
• Generous vacation accrual and paid holiday schedule

Keywords: Applied Medical Distribution Corporation, Rancho Santa Margarita , Quality Engineer II, Other , Rancho Santa Margarita, California