Medline Industries is seeking a Manufacturing Quality Engineer to oversee quality standards and process improvements in Waukegan, IL. The role requires a background in engineering or a related field, with a focus on quality assurance in manufacturing, particularly within the medical device industry
Job Summary
The role involves independently setting quality standards and leading efforts to develop testing, sampling, and training methods for manufacturing processes.
Candidates will be responsible for managing process validation, designing experiments to reduce variation, and ensuring compliance with domestic and international regulations.
Medline offers a competitive total rewards package including health insurance, 401(k) contributions, paid time off, and opportunities for career growth within a growing worldwide organization.
Matching Summary
Match Score: 85
Medline Industries is seeking a Manufacturing Quality Engineer to oversee quality standards and process improvements in Waukegan, IL. The role requires a background in engineering or a related field, with a focus on quality assurance in manufacturing, particularly within the medical device industry.
Salary
Base: $79,000.00 - $119,000.00 Annual; Bonus/Equity: Eligible for bonus/incentive; Benefits: Health insurance, life/disability, 401(k), PTO
Skills & Requirements
Must-have
Bachelor's degree in Engineering or Science
2+ years Quality or Engineering experience
Statistical Process Control (SPC) methods
CAPA and SCAR implementation
Device Master Records (DMR) creation
ISO13485 and 21 CFR 820 compliance
Intermediate Microsoft Excel skills
Nice-to-have
Medical device industry background
Supplier qualification leadership
510K submission support experience
Design control activities expertise
Risk management knowledge
CE technical file preparation
Cross-functional collaboration skills
Key Requirements
Bachelor's degree in Engineering, Science, Math, or related field
Minimum 2 years of experience in Quality or Engineering
Preferred 2 years of industry experience in Medical Devices or Drugs
Working knowledge of 21 CFR 820 and ISO13485 standards