Quality Engineer, Medical Device Manufacturing

Job overview

The Quality Engineer role is onsite in Salt Lake City, UT. Compensation is not specified. The role supports quality assessment and improvement for Class II/III medical device manufacturing in a regulated environment.

What you'll do

• Lead manufacturing quality assessments, process audits, and remediation
• improve yield and reduce defects and scrap
• review process and test method validation
• conduct statistical and risk analyses
• support CAPA, nonconformance, deviation, supplier quality, and root-cause investigations
• monitor quality metrics
• support FDA, ISO 13485, MDSAP, and other audits
• maintain quality records and collaborate across manufacturing, engineering, research and development, supplier quality, regulatory affairs, and operations.

What we're looking for

Skills & competencies

quality engineer

medical devices

manufacturing quality

process validation

capa

supplier quality

regulatory compliance

salt lake city ut

katalyst healthcares & life sciences

Work arrangement

• Weekend coverage required

Why this role

The posting seeks 8+ years of medical device manufacturing quality engineering experience and hands-on expertise in process validation, TMV, SPC, MSA, PFMEA, and CAPA.

About the employer

Katalyst Healthcares & Life Sciences is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.