Senior Quality Engineer, Medical Devices & Design Control

Confluent Medical Technologies; Laguna Niguel (CA); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading medical device firm located in Laguna Niguel, California, is seeking a Quality Engineer with a strong background in risk management and statistical analysis. The role involves developing and maintaining risk management files, providing guidance on statistical topics, and ensuring compliance with industry regulations like FDA and ISO standards. Ideal applicants should have a BS or MS in engineering and substantial experience in medical device product development.

Qualifications

• 5 years of experience in Quality in a medical device environment or equivalent.
• Experience with FDA, ISO 13485, and EU MDR Design Control requirements.
• Strong statistical data analysis skills.

Responsibilities

• Lead generation and maintenance of risk management files.
• Provide guidance on statistical analysis topics.
• Participate in design changes to meet revised specifications.

Skills

Statistical data analysis

Knowledge of FDA regulations

Design Control experience

Risk Management

Critical thinking

Education

BS in a related engineering discipline

MS in a related engineering discipline

Tools

Minitab

Job description

A leading medical device firm located in Laguna Niguel, California, is seeking a Quality Engineer with a strong background in risk management and statistical analysis. The role involves developing and maintaining risk management files, providing guidance on statistical topics, and ensuring compliance with industry regulations like FDA and ISO standards. Ideal applicants should have a BS or MS in engineering and substantial experience in medical device product development.