Not specified (assumed hybrid based on industry norms)
Bachelor's degree in engineering or science
4+ years quality or engineering experience
Knowledge of 21 cfr 820 and iso13485
Medline Industries is seeking a Senior Quality Engineer for their Advanced Wound Care division. The role involves managing quality standards, process control, and supplier management, requiring significant experience in quality assurance within the medical device sector
Job Summary
The role involves independently setting quality standards and leading efforts to develop testing methods for advanced wound care products.
Candidates must manage process validation, design control files, and ensure compliance with domestic and international regulations like MDD/MDR.
Medline offers a competitive salary range of $101,000 to $152,000 along with comprehensive benefits including health insurance and 401(k) contributions.
Matching Summary
Match Score: 85
Medline Industries is seeking a Senior Quality Engineer for their Advanced Wound Care division. The role involves managing quality standards, process control, and supplier management, requiring significant experience in quality assurance within the medical device sector.
Salary
Base: $101,000.00 - $152,000.00 Annual; Bonus/Equity: Eligible for bonus and/or incentive; Benefits: Health insurance, life/disability, 401(k), PTO
Skills & Requirements
Must-have
Bachelor's degree in Engineering or Science
4+ years Quality or Engineering experience
Knowledge of 21 CFR 820 and ISO13485
Experience with Design Control and Risk Management
Advanced Microsoft Excel skills including Pivot tables
Nice-to-have
Six Sigma or Lean methodology knowledge
5+ years medical device industry experience
Experience leading cross-functional teams
Supplier qualification and management expertise
Ability to work with minimal supervision
Key Requirements
Bachelor's degree in Engineering, Science, Math
Minimum 4 years of relevant experience
Proficiency with 21 CFR 820, ISO13485, and sterilization standards