Quality Engineering Supervisor - Night Shift

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 position involves managing and overseeing a team of Quality Technicians while providing guidance, training, and performance feedback.
  • Cardinal Health offers a comprehensive benefits package including medical, dental, vision coverage, 401k savings plan, and paid time off.

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, parental leave

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
  • Night shift availability 8PM-4AM

Nice-to-have

  • Data mining and trend analysis skills
  • CE marking documentation support
  • ASQ CQE or CMQ/OE certification
  • Cross-functional collaboration abilities
  • Proactive risk mitigation approach

Key Requirements

  • Bachelor's degree in engineering preferred
  • 4+ years of relevant experience required
  • Prior medical device manufacturing experience required
  • Ability to perform internal quality audits
  • Knowledge of Design control in FDA regulated industry

Work Rights

Not specified

Tailored Resume

Cover Letter