Sr. Engineer, Quality Operations

BAXTER HEALTHCARE PTY AUS

Base: $96,000 - $115,000 annually; bonus/equity: e...
Fda regulatory agency interaction experience
Gmp manufacturing environment knowledge
Root cause investigation and capa leadership
This role is responsible for leading compliance, validation, investigations, and corrective action projects within designated quality areas

Job Summary

  • This role is responsible for leading compliance, validation, investigations, and corrective action projects within designated quality areas.
  • The position requires extensive interaction with FDA and other regulatory agencies to ensure product compliance and safety.
  • Baxter offers comprehensive benefits including medical coverage starting day one, a 401(k) match, and up to 35 days of paid time off.

Matching Summary

This role is responsible for leading compliance, validation, investigations, and corrective action projects within designated quality areas.

Salary

Base: $96,000 - $115,000 annually; Bonus/Equity: Eligible for discretionary bonuses and long-term incentives; Benefits: Comprehensive health, dental, 401(k), and PTO included

Skills & Requirements

Must-have

  • FDA regulatory agency interaction experience
  • GMP manufacturing environment knowledge
  • Root cause investigation and CAPA leadership

Nice-to-have

  • Six Sigma green belt certification
  • ASQ CQE certification preferred
  • Cross-functional team collaboration skills

Key Requirements

  • BA or BS in Engineering with 4+ years experience
  • Prior experience interacting with FDA and regulatory agencies
  • Knowledge of sterilization, cleaning, and validation processes

Work Rights

Must be authorized to work in the U.S.

Tailored Resume

Cover Letter