Lead Quality Systems Specialist

Fresenius Medical Care

Base: $117,000.00 - $196,000.00 annually; bonus/eq...
6-8 years related experience
Bachelor's degree required
Recall strategy and tracking
This role acts as a subject matter expert to support the organization with initial compliance and ongoing preparation for quality systems processes in manufacturing

Job Summary

  • This role acts as a subject matter expert to support the organization with initial compliance and ongoing preparation for quality systems processes in manufacturing.
  • The position requires managing corrections and removals, including ensuring effective recall strategies, monthly status updates to the FDA, and coordinating material destructions.
  • Candidates will benefit from a comprehensive benefits package including medical, dental, vision insurance, a 401(k) with company match, and potential performance-based bonuses.

Matching Summary

This role acts as a subject matter expert to support the organization with initial compliance and ongoing preparation for quality systems processes in manufacturing.

Salary

Base: $117,000.00 - $196,000.00 annually; Bonus/Equity: Potential for performance-based bonuses depending on company and individual performance; Benefits: Medical, dental, vision, 401(k) with match, paid time off, parental leave

Skills & Requirements

Must-have

  • 6-8 years related experience
  • Bachelor's degree required
  • Recall strategy and tracking
  • FDA regulatory knowledge
  • Internal audit execution
  • Risk assessment and mitigation

Nice-to-have

  • Advanced degree preferred
  • Strong verbal communication skills
  • High stress environment adaptability
  • Mentoring and training staff
  • Cross-functional collaboration

Key Requirements

  • 6-8 years of related experience
  • Bachelor's Degree (Advanced preferred)
  • Prior corrections and removals experience
  • Proficient understanding of USA, Health Canada, and Mexico regulations

Work Rights

Not specified

Tailored Resume

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