Quality Engineer I - Medical Devices & Compliance

Mindlance; Irvine; On-site; GBP 35,000 - 50,000; Full time

Job summary

A medical device company in Irvine is seeking a Quality Engineer responsible for maintaining quality and control of manufacturing processes. The role involves leading investigations, developing plans for quality assurance, and ensuring compliance with FDA regulations and ISO standards. Preferred candidates will have a Bachelor’s degree in Engineering and experience in a regulated environment. This position offers an opportunity to contribute to product performance and quality within a dynamic team.

Qualifications

• 2 years of relevant experience in a regulated industry preferred.
• Knowledgeable of FDA regulations and ISO 13485 standard.

Responsibilities

• Develop and execute plans for quality and control.
• Lead investigations into quality issues to identify root cause.
• Monitor and analyze product performance of medical devices.
• Perform troubleshooting of customer returned devices.
• Develop tools to communicate complex technical problems.
• Ensure compliance with quality system policies.

Skills

Project management

Data analysis

Root cause analysis

Communication

Risk determination

Education

Bachelor’s degree in Engineering

Job description

A medical device company in Irvine is seeking a Quality Engineer responsible for maintaining quality and control of manufacturing processes. The role involves leading investigations, developing plans for quality assurance, and ensuring compliance with FDA regulations and ISO standards. Preferred candidates will have a Bachelor’s degree in Engineering and experience in a regulated environment. This position offers an opportunity to contribute to product performance and quality within a dynamic team.