CAPA Engineer

Key Responsibilities

• Perform oversight and approval of Corrective and Preventative Actions (CAPA)
• Conduct experiments to prove hypotheses
• Implement statistical techniques to determine sample sizes and levels of confidence
• Implement statistical process controls to monitor validated processes
• Work with process owners to design engineering test protocols and use a data-driven approach to collect, analyze and summarize data into engineering reports
• Generate protocols and reports for Installation, Operational and Performance Qualification (IQ, OQ, PQ)
• Collaborate with design and manufacturing teams to assess device risk profile and failure modes in design (dFMEA) and manufacturing (pFMEA)

Position Requirements

• Bachelor’s degree in an Engineering or Science, Technology, Engineering, and Mathematics (STEM) field or related education and experience
• Effective oral and written communication skills
• Excellent problem solving/critical thinking
• Able to work effectively in cross-functional teams
• Working knowledge of Microsoft Office, including Word, Excel, and Outlook
• Able to conduct thorough investigations and analyses to identify the underlying causes of problems or failures and develop effective solutions to prevent their recurrence
• Able to comprehend and think critically about a multitude of varying processes throughout the company
• Strong understanding of root cause analysis, hypothesis testing, and problem solving to perform investigations and provide objective evidence of issues present

Preferred

• Experience in ETQ Reliance or equivalent electronic Quality Management software
• Process improvement or project management experience
• Understanding of manufacturing, quality and risk management standards

Benefits

• Competitive compensation range: $72000 - $78000 / year (California)
• Comprehensive benefits package
• Training and mentorship opportunities
• On-campus wellness activities
• Educational reimbursement program
• 401(k) program with discretionary employer match
• Generous vacation accrual and paid holiday schedule