A Product Quality Engineer evaluates and tests products and manufacturing systems, to ensure that products are produced that meet quality and performance standards as well as safety and regulatory requirements. Develops product quality standards and monitors production and product testing.
Quality Engineer at LHH Quality Engineer at LHH in Mundelein, Illinois Posted in 1 day ago.
Type:
full-time
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 San Francisco Fair Chance Ordinance
