Senior Medical Device QA Engineer - Compliance & CI

Nihon Kohden Orange Med; Santa Ana (CA); On-site; USD 85,000 - 123,000; Full time

Job summary

Nihon Kohden Orange Med is seeking a Quality Assurance Engineer located in Santa Ana, California. This role focuses on overseeing compliance with FDA and ISO regulations, providing advanced quality engineering support, and conducting audits. Candidates should have a Bachelor's degree in engineering, 3-5 years of experience in a regulated setting, and strong analytical skills. The position offers a salary range between $85,000 and $123,000 annually with opportunities for professional growth.

Qualifications

• Minimum three-five years of quality engineering experience in regulated environment, preferably medical device.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and medical device quality systems.
• Experience with NCR/NMR, complaint investigations, validations, and supplier quality.

Responsibilities

• Ensure compliance with US-FDA, MDD/MDR, and ISO 13485.
• Provide advanced quality engineering support for manufacturing operations.
• Conduct internal quality audits to ensure compliance.

Skills

Analytical skills

Technical problem-solving

Communication skills

Collaborative work

Microsoft Office proficiency

Education

Bachelor’s degree in engineering or biological science

Tools

Quality management software systems

Job description

Nihon Kohden Orange Med is seeking a Quality Assurance Engineer located in Santa Ana, California. This role focuses on overseeing compliance with FDA and ISO regulations, providing advanced quality engineering support, and conducting audits. Candidates should have a Bachelor's degree in engineering, 3-5 years of experience in a regulated setting, and strong analytical skills. The position offers a salary range between $85,000 and $123,000 annually with opportunities for professional growth.