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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.
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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
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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.
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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