Sr. Engineer, Quality Operations

Baxter

Base: $96,000 - $115,000 annually; bonus/equity: d...
Fda regulatory interaction experience
Gmp manufacturing environment knowledge
Root cause investigation leadership
The role focuses on leading compliance, validation, and corrective action projects to ensure product quality and regulatory adherence

Job Summary

  • The role focuses on leading compliance, validation, and corrective action projects to ensure product quality and regulatory adherence.
  • Candidates must possess strong scientific analysis skills to perform root cause investigations and drive continuous improvement in manufacturing processes.
  • Baxter offers comprehensive benefits including medical coverage starting day one, a 401(k) match, and paid time off ranging from 20 to 35 days.

Matching Summary

The role focuses on leading compliance, validation, and corrective action projects to ensure product quality and regulatory adherence.

Salary

Base: $96,000 - $115,000 annually; Bonus/Equity: Discretionary bonuses and long-term incentives possible; Benefits: Medical, dental, 401(k), ESPP, PTO

Skills & Requirements

Must-have

  • FDA regulatory interaction experience
  • GMP manufacturing environment knowledge
  • Root cause investigation leadership
  • NCR and CAPA project management
  • Engineering degree with 4+ years experience

Nice-to-have

  • Six Sigma green belt certification
  • ASQ CQE certification preferred
  • Cross-functional team collaboration skills
  • Mentoring and coaching abilities
  • Data integrity initiative support

Key Requirements

  • BA or BS in Engineering required
  • Minimum 4 years related experience
  • Prior FDA interaction experience mandatory
  • US work authorization required (no sponsorship)

Work Rights

Must be authorized to work for any employer in the U.S.

Tailored Resume

Cover Letter