Quality Engineer

Applied Medical•Rancho Santa Margarita, CA

74d•Onsite

About The Position

The Quality Engineer supports product quality, regulatory compliance, and manufacturing excellence at Applied Medical by working within a cross-functional team to develop, maintain, and improve quality systems and documentation. This role is well-suited for candidates with a background in quality engineering, process engineering, or medical device quality assurance who are looking to apply their technical skills in a regulated manufacturing environment. The Quality Engineer contributes directly to process validation, risk management, and documentation integrity across the product lifecycle.

Requirements

Bachelor's degree in engineering, physical sciences, biological sciences, or another technical discipline; or equivalent experience.
Strong technical writing skills with the ability to create and maintain SOPs, test methods, and quality documentation.
Analytical, meticulous, and detail-oriented approach to quality and process-related work.
Ability to work independently and collaboratively within a cross-functional team environment.
Strong organizational skills with the ability to multitask and prioritize effectively.
Effective oral and written communication and presentation skills.
Ability to read, write, and speak English and comprehend work and safety instructions.

Nice To Haves

Training in quality systems including Quality System Regulation and Good Manufacturing Practices (QSR/GMP) and relevant International Organization for Standardization (ISO) standards.
Understanding of quality principles within a regulated manufacturing or medical device environment.
Minimum of one year of experience in the medical device industry.

Responsibilities

Review and approve Device Master Record (DMR) documents, as well as protocols and reports for Installation, Operational, and Performance Qualification (IQ, OQ, PQ)
Create and validate test methods for design verification and manufacturing inspection testing by utilizing techniques such as measurement system analysis and Gage Repeatability & Reproducibility (Gage R&R)
Document and review Non-Conformance Investigations (NCIR)
Propose, investigate, and coordinate clean room maintenance and improvement projects
Develop and maintain Environmental Monitoring Plans and Reports for top-level manufacturing areas, performing investigations and root cause analyses for any abnormalities in environmental data trends.
Support Corrective and Preventative Actions (CAPA), Internal and External Audit
Investigate root causes for quality and manufacturing issues, document results and implement corrective actions
Create and update Standard Operating Procedures (SOPs) and Job Aids
Collaborate with design and manufacturing teams to assess device risk profile, identify failure modes in manufacturing (pFMEA)
Conduct experiments to prove hypotheses and implement statistical techniques to determine appropriate sample sizes and levels of confidence
Assist with training of new team members