Sr. Engineer, Quality Operations

BAXTER HEALTHCARE PTY AUS

Skaneateles, NY, United States
Base: $96,000 - $115,000 annually; bonus/equity: d...
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Root cause investigations
Corrective and preventative action
Regulatory agency rules and guidelines
** Baxter Healthcare is seeking a Senior Engineer for Quality Operations in Skaneateles, NY, to ensure compliance and lead quality improvement initiatives. The role requires a strong background in regulatory processes, team leadership, and quality management within a manufacturing environment, while promoting a culture of collaboration and accountability. **

Job Summary

  • Responsible for compliance, validation, investigations and corrective action projects on designated Quality process/area responsibilities.
  • Lead assessments for regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices.
  • The Quality function values both working together as a team and independently.

Matching Summary

Match Score: 75

** Baxter Healthcare is seeking a Senior Engineer for Quality Operations in Skaneateles, NY, to ensure compliance and lead quality improvement initiatives. The role requires a strong background in regulatory processes, team leadership, and quality management within a manufacturing environment, while promoting a culture of collaboration and accountability. **

Salary

Base: $96,000 - $115,000 annually; Bonus/Equity: Discretionary bonuses, commission, and/or long-term incentive; Benefits: Medical and dental coverage, life insurance, disability, ESPP, 401(k), paid time off

Skills & Requirements

Must-have

  • Root cause investigations
  • Corrective and preventative action
  • Regulatory agency rules and guidelines
  • Quality System Documentation
  • Product compliance to specifications
  • GMP/manufacturing environment

Nice-to-have

  • Continuous improvement philosophies
  • Cross-functional team collaboration
  • Scientific analysis and troubleshooting
  • Team leader with management skills

Key Requirements

  • 4+ years related experience
  • Six Sigma green belt or ASQ CQE certification
  • Prior experience interacting with the FDA
  • Ability to work effectively with multi-department and multi-site teams
  • Ability to manage and organize complex technical problems

Work Rights

Authorized to work for any employer in the U.S.

Tailored Resume

Cover Letter