Senior Quality Engineer - Hands-on QA Leader, Med Devices

Praxt Talent LLC; Salt Lake City (UT); On-site; USD 90,000 - 130,000; Full time

Job summary

A leading company in medical device manufacturing is seeking a Senior Quality Engineer to enhance their quality assurance processes. This role involves ensuring product quality, compliance with regulatory standards, and driving improvements through statistical analysis. The ideal candidate will have a strong background in quality engineering and experience with FDA regulations. You will be responsible for overseeing product and process qualifications and collaborating across teams to elevate quality standards.

Qualifications

• 5+ years in quality engineering within the medical device sector.
• Strong understanding of validation processes in product lifecycle management.
• Ability to manage multiple projects with minimal supervision.

Responsibilities

• Act as a quality support function, embedding quality processes into manufacturing.
• Monitor scrap costs and spearhead initiatives to improve yield.
• Lead risk assessment activities including hazard analysis.

Skills

Statistical techniques

FDA GMP practices

Cross-functional collaboration

Risk management

Education

Bachelors degree in engineering

Job description

A leading company in medical device manufacturing is seeking a Senior Quality Engineer to enhance their quality assurance processes. This role involves ensuring product quality, compliance with regulatory standards, and driving improvements through statistical analysis. The ideal candidate will have a strong background in quality engineering and experience with FDA regulations. You will be responsible for overseeing product and process qualifications and collaborating across teams to elevate quality standards.