Quality Assurance Engineer
$85,000–$123,000 year
On-site · Santa Ana, California, United States
Job Summary
Quality Assurance Engineer III responsible for enabling product quality, manufacturing process excellence, and Quality Management System compliance in a regulated medical device environment. Leads advanced quality initiatives across new product development, sustaining engineering, supplier quality, and manufacturing operations; supports manufacturing in-process validation, material review boards, deviation investigations, CAPA, supplier audits, and quality plans. Requires working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and related regulations; strong analytical and problem-solving skills; ability to read engineering drawings and collaborate cross-functionally; and a Bachelor’s degree in engineering or a related field with 3-5 years of quality engineering experience. Compensation range is $85,000–$123,000 annually; occasional domestic travel and office-based role in Santa Ana, CA.
Required Qualifications
- Bachelor's degree in engineering, biological science or related technical field
- Minimum three-five years of quality engineering experience in a highlighted regulated environment, medical device preferred
- Strong working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and medical device quality systems
- Experience with NCR/NMR, complaint investigations, validations, supplier quality, and audits
- Experience supporting product development and design control activities preferred
- Knowledge of statistical analysis, sampling plans, SPC, and quality data trending preferred
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