Quality Engineer - Personal Protective Equipment

Medline Industries LP

Base: $79,000.00 - $119,000.00 annually; bonus/equ...
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Bachelor's degree in engineering or science
2+ years quality or engineering experience
Statistical process control (spc) methods
** Medline Industries LP is seeking a Quality Engineer specializing in Personal Protective Equipment. The role involves managing quality standards, process improvements, and vendor management to ensure product compliance and functionality within the medical device sector. **

Job Summary

  • The role involves independently setting basic quality standards and leading efforts to develop testing and sampling methods for Personal Protective Equipment.
  • Candidates will be responsible for generating and maintaining Device Master Records, product specifications, and CE technical files in compliance with regulations.
  • Medline offers a competitive total rewards package including health insurance, 401(k) contributions, and paid time off for eligible employees.

Matching Summary

Match Score: 75

** Medline Industries LP is seeking a Quality Engineer specializing in Personal Protective Equipment. The role involves managing quality standards, process improvements, and vendor management to ensure product compliance and functionality within the medical device sector. **

Salary

Base: $79,000.00 - $119,000.00 annually; 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
  • Device Master Records (DMR) generation
  • CAPA and SCAR implementation

Nice-to-have

  • Experience with Medical Device industry
  • 510K submission support knowledge
  • Supplier qualification leadership
  • Strong time management skills
  • Intermediate Microsoft Excel proficiency

Key Requirements

  • Bachelor's degree required
  • Minimum 2 years of relevant experience
  • Knowledge of 21 CFR 820 and ISO13485

Work Rights

Not specified

Tailored Resume

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