CAPA Engineer

Applied Medical•Rancho Santa Margarita, CA

1d•Onsite

About The Position

Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions. Collaboration is a fundamental part of our organization's culture and is essential to our continued success. As such, the successful candidate for this position is expected to work on-site, enabling them to engage fully with colleagues and contribute to cross-functional initiatives. Therefore, the ability to work collaboratively and contribute to a positive and supportive team environment is a key requirement for this role. As a Quality Engineer I, you will learn and develop skills to support medical device quality through investigation of non-conformances, root cause analysis, risk assessment, and implementation of corrective and preventive actions as part of a cross-functional team.

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
Ability to work effectively in cross-functional teams
Working knowledge of Microsoft Office, including Word, Excel, and Outlook
Ability to conduct thorough investigations and analyses to identify the underlying causes of problems or failures and develop effective solutions to prevent their recurrence
Ability to comprehend and think critically about a multitude of varying processes throughout the company
Being able to objectively analyze a situation and make a reasonable judgement is essential
Solid understanding of root cause analysis, hypothesis testing, and problem solving to perform investigations and provide objective evidence of issues present

Nice To Haves

Experience in ETQ Reliance or equivalent electronic Quality Management software
Process improvement or project management experience
Working knowledge of statistics as it relates to quality metrics and confidence intervals.
Understanding of manufacturing, quality and risk management standards

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
Perform root cause investigations for design and manufacturing
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)

Benefits

Competitive compensation range: $72000 - $78000 / year (California).
Comprehensive benefits package.
Training and mentorship opportunities.
On-campus wellness activities.
Education reimbursement program.
401(k) program with discretionary employer match.
Generous vacation accrual and paid holiday schedule.
Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply.
Our total reward package reflects our commitment to employee growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life.
All compensation and benefits are subject to plan documents and written agreements.