Quality Engineer

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

Quality Engineer | Medical Device Manufacturing

I'm partnering with an established manufacturer in the healthcare industry seeking an experienced Quality Engineer to join their team.

This role will play a critical part in supporting product quality, validation activities, investigations, corrective actions, and continuous improvement initiatives within a regulated manufacturing environment. The ideal candidate is analytical, detail-oriented, and passionate about driving quality excellence.

What You'll Be Doing:

• 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

What We're Looking For:

• Bachelor's degree in Engineering (Quality, Industrial, Mechanical, or related field)
• 5+ years of Quality Engineering or Quality Assurance experience
• Knowledge of FDA regulations and medical device quality systems
• Experience with CAPA, SCARs, non-conformances, complaints, and root cause investigations
• Familiarity with ISO 13485, ISO 14971, and device quality requirements
• Strong analytical, project management, communication, and technical writing skills

Work Schedule

Onsite

Compensation

$80-90k base

Benefits

• Medical, dental, vision, paid sick leave where applicable by state law

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.lhh.com/us/en/candidate-privacy

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers