Quality CAPA Engineer I — Medical Devices

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, 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.