CAPA Engineer

Applied Medical; Rancho Santa Margarita (CA); On-site; USD 72,000 - 78,000; Full time

Benefits offered by this job

Competitive compensation

Comprehensive benefits package

Education reimbursement program

401(k) program with employer match

Generous vacation and holidays

Job summary

Applied Medical, a leading medical device company, is seeking a Quality Engineer I to join our on-site team in California. You will support medical device quality through CAPA investigations, root cause analysis, risk assessment, and CAPA implementation as part of a cross-functional team.

You will collaborate with design and manufacturing to assess device risk, generate IQ/OQ/PQ protocols, and contribute to improving our Quality Management System while advancing through hands-on learning.

Qualifications

• Bachelor's degree in Engineering or STEM (required).
• Strong problem solving and critical thinking skills.
• Ability to work effectively in cross functional teams.

Responsibilities

• Oversee and approve CAPAs.
• Conduct experiments to test hypotheses and collect data.
• Apply statistical techniques to determine sample sizes and confidence levels.
• Implement statistical process controls for validated processes.
• Design engineering test protocols and generate data-driven reports.
• Lead root cause investigations for design and manufacturing.
• Prepare IQ, OQ, PQ protocols and reports.
• Collaborate with design and manufacturing on risk assessment (dFMEA, pFMEA).

Skills

CAPA oversight

Root cause analysis

Statistical methods

Data analysis

Cross-functional teamwork

QMS knowledge

Problem solving

Effective communication

Education

Bachelor's degree in Engineering or STEM

Tools

ETQ Reliance

Job description

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.

Position Description

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.

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
• 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 profileand failure modes in design (dFMEA)and manufacturing (pFMEA)

Success in This Role Looks Like

• Exhibiting a strong technical understanding of the product lines and projects
• Performing in-depth, comprehensive investigations
• Developing interpersonal connections and relationships with others to effectively accomplish project objectives and deliverables
• Leading moderate to high-risk investigations with minimal guidance or direction
• Demonstrating a strong understanding of Applied’s Quality Management System (QMS) and effectively troubleshoot challenges or obstacles that may affect project timelines

Position Requirements

This position requires the following skills and attributes:

• 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

Preferred

The following skills and attributes are preferred:

• 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 managementstandards

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.

Equal Opportunity Employer

Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.