Hiring: Quality Engineer Company: Applied Medical Location: Rancho Santa Margarita, CA Job Posted Time: 2026-09-17 13:12:42 Target Skills & Keywords : Quality Assurance, R, Regulatory Compliance, Risk Management About the job Experience: •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. •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. Required Skills: •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 Qualifications: •This Position Requires the Following Skills and Attributes •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. •Demonstrated capacity 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. •Demonstrated capacity to read, write, and speak English and comprehend work and safety instructions. •The Following Skills and Attributes Are Preferred •Training in quality systems including Quality System Regulation and Good Manufacturing Practices (QSR/GMP) and relevant International Organization for Standardization (ISO) standards. Compensation: •$71,000 - $75,000 / year •Competitive benefits and rewards package •401(k) program with discretionary employer match Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!