QA Systems Engineer - Onsite Weekdays
Baxter · Medina, NY
QualityFull-time$76k–$105kCompany career page
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Role summary
Quality Assurance Systems Engineer role at Baxter's Medina, New York facility, reporting to the QA Systems Manager. Responsibilities include executing equipment and process validations, managing change controls, leading process improvement initiatives, and supporting cross-functional teams within a regulated manufacturing environment.
What they're looking for
- Bachelor's degree in Engineering
- 1-3 years of engineering experience preferred
- Process improvement training or experience (Six Sigma, Lean preferred)
- Manufacturing or medical device industry experience preferred
- Knowledge of cGMP regulations and Good Manufacturing Practices
- Strong technical communication and root cause analysis skills
- Ability to prioritize multiple tasks and meet tight deadlines
What you'll be doing
- Execute complex validations including IQ, OQ, PQ, and MSA protocols for processes, equipment, and systems
- Own and drive change control management based on procedural requirements
- Lead or assist process improvement projects focused on scrap and defect reduction
- Collaborate with cross-functional teams and communicate with external auditors
- Prepare technical reports, data-driven analysis, and documentation for assigned projects
Privacy & handoff
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