Quality Engineer Iii – Quality Complaint Management

PPD (Thermo Fisher)

Minnesota, US
Base: $75,800.00–$113,675.00; bonus/equity: variab...
Bachelor's degree in engineering or life sciences
3-5 years qa experience in regulated industry
Strong knowledge of cgmp and iso standards
This role involves overseeing the customer complaint quality management system while ensuring compliance with FDA, cGMP, and ISO regulations

Job Summary

  • This role involves overseeing the customer complaint quality management system while ensuring compliance with FDA, cGMP, and ISO regulations.
  • The position requires collaborating cross-functionally to resolve quality issues through robust investigations and managing customer communications.
  • Candidates will benefit from a comprehensive Total Rewards package including medical plans, 401(k), and paid parental leave.

Matching Summary

This role involves overseeing the customer complaint quality management system while ensuring compliance with FDA, cGMP, and ISO regulations.

Salary

Base: $75,800.00–$113,675.00; Bonus/Equity: Variable annual bonus eligible; Benefits: Comprehensive medical, dental, vision, 401(k), PTO, and ESPP

Skills & Requirements

Must-have

  • Bachelor's Degree in Engineering or Life Sciences
  • 3-5 years QA experience in regulated industry
  • Strong knowledge of cGMP and ISO standards
  • Expertise in root cause analysis methodologies
  • Proficiency with Quality Management Systems (QMS)

Nice-to-have

  • ASQ certifications (CQE, CQA) desired
  • Ability to travel up to 10%
  • Additional language skills are a plus
  • Strong project management and organizational skills
  • Effective interpersonal skills to influence teams

Key Requirements

  • Bachelor's Degree required
  • 3-5 years experience in pharmaceutical or biotech QA
  • ASQ certifications preferred
  • Working knowledge of statistical analysis tools

Work Rights

Not specified

Tailored Resume

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