Quality Engineer - Medical Device Quality & CAPA Expert

LHH; Mundelein (IL); On-site; USD 80,000 - 90,000; Full time

Benefits offered by this job

Medical benefits

Paid time off

Job summary

LHH is seeking a Quality Engineer for a medical device manufacturing environment. The role emphasizes driving product quality, supporting validation, and leading corrective actions within a regulated setting.

The ideal candidate has extensive QA experience, strong analytical and writing skills, and a solid understanding of FDA, GMP, ISO standards. This onsite position offers a competitive base salary and comprehensive benefits.

Qualifications

• 5+ years of Quality Engineering or QA experience.
• Familiarity with FDA regulations and medical device QMS.
• Experience with CAPA, non-conformances, SCARs, and root cause investigations.
• ISO 13485, ISO 14971 knowledge.

Responsibilities

• Lead quality investigations, non-conformance assessments, CAPAs, and corrective actions
• Support validation activities and quality system initiatives
• Partner with operations teams to improve manufacturing processes and product quality
• Conduct root cause analysis and implement sustainable solutions
• Support internal and external audits
• Utilize statistical tools and engineering principles to drive continuous improvement
• Ensure compliance with FDA regulations, GMP requirements, and ISO standards

Skills

CAPA

Root cause analysis

Analytical mindset

Project management

Communication

Technical writing

GMP knowledge

Education

Bachelor's degree in Engineering

Tools

Minitab

Statistical software

Job description

LHH is seeking a Quality Engineer for a medical device manufacturing environment. The role emphasizes driving product quality, supporting validation, and leading corrective actions within a regulated setting.

The ideal candidate has extensive QA experience, strong analytical and writing skills, and a solid understanding of FDA, GMP, ISO standards. This onsite position offers a competitive base salary and comprehensive benefits.