QA Engineer, Medical Devices — Quality & Compliance

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

Job summary

Orange Med in Santa Ana, California, is hiring a Quality Assurance Engineer responsible for improving product quality and ensuring compliance within a regulated medical device environment. You will support manufacturing processes and quality management system compliance, lead complex quality initiatives, and drive continuous improvement efforts. Candidates should hold a Bachelor’s degree and have at least 3 years of relevant experience. Compensation ranges from $85,000 to $123,000 depending on experience.

Qualifications

• Bachelor’s degree in engineering, biological science or a related technical field required.
• 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.

Responsibilities

• Assure quality system processes are in compliance with US-FDA regulations.
• Provide advanced quality engineering support for manufacturing operations.
• Conduct internal quality audits to ensure compliance with the Quality System.

Skills

Analytical skills

Problem-solving skills

Communication skills

Knowledge of FDA regulations

Experience with ISO standards

Statistical analysis

Education

Bachelor’s degree in engineering or related field

3-5 years of quality engineering experience

Tools

Microsoft Office

Quality management software

Job description

Orange Med in Santa Ana, California, is hiring a Quality Assurance Engineer responsible for improving product quality and ensuring compliance within a regulated medical device environment. You will support manufacturing processes and quality management system compliance, lead complex quality initiatives, and drive continuous improvement efforts. Candidates should hold a Bachelor’s degree and have at least 3 years of relevant experience. Compensation ranges from $85,000 to $123,000 depending on experience.