Quality Engineering Supervisor

Cardinal Health

Base: $70,400 - $100,500; bonus/equity: no bonus e...
Gmp 21 cfr 820 compliance
Iso 13485 quality system knowledge
Medical device manufacturing experience
This role is critical for ensuring adherence to FDA regulations and ISO standards within medical device manufacturing operations

Job Summary

  • This role is critical for ensuring adherence to FDA regulations and ISO standards within medical device manufacturing operations.
  • The ideal candidate will leverage expertise to proactively identify and mitigate quality risks while contributing to continuous improvement.
  • Cardinal Health offers a wide variety of benefits including medical, dental, vision coverage, 401k savings plan, and paid parental leave.

Matching Summary

This role is critical for ensuring adherence to FDA regulations and ISO standards within medical device manufacturing operations.

Salary

Base: $70,400 - $100,500; Bonus/Equity: No bonus eligible; Benefits: Medical, dental, vision, HSA, 401k, PTO, flexible spending accounts

Skills & Requirements

Must-have

  • GMP 21 CFR 820 compliance
  • ISO 13485 quality system knowledge
  • Medical device manufacturing experience
  • Internal quality audit execution
  • Statistical analysis DOE ANOVA
  • Supplier management oversight
  • Root cause analysis CAPA

Nice-to-have

  • Data mining and trend analysis
  • CE marking documentation support
  • Cross-functional collaboration skills
  • Proactive risk mitigation approach
  • Self-motivated team leadership

Key Requirements

  • Bachelor's degree in engineering preferred
  • ASQ CQE, CMQ/OE, or CQA/CBA certification preferred
  • 4+ years of experience required
  • Prior medical device manufacturing experience required
  • Ability to perform internal quality audits

Work Rights

Not specified

Tailored Resume

Cover Letter