Quality Engineer I, QA Systems

This is where  your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride.  Your Role at Baxter: Coordinate the validation program to ensure the facility and all equipment, processes and systems are in a validated state of control, by maintaining Validation Master Plans, creating and compiling validation packages, providing technical expertise and information resources to other departments Subject Matter Expert (SME) on validation to ensure compliance to Regulatory and Corporate requirements. Create validation packages for equipment/process, computer systems and test method validations to demonstrate a validated state of control. Ensure Data Integrity elements are integrated in validations where applicable. Ensure that validation protocols are written, executed, and documented in accordance with Corporate Quality Policies and Regulatory requirements. Utilize the Trackwise system for Change Control Management practices and addressing/resolving Non-Conformances Assist Engineering and Production with commissioning activities where applicable General Expectations: The top two priorities for all Baxter Alliston employees are Safety and Quality: Safety :  Support our goal to achieve a “Zero Harm Environment”, by ensuring the safety of yourself and your co-workers through:  following all safety procedures  understanding potential hazards in your area  wearing appropriate PPE  reporting all incidents / near-misses / concerns  embracing 6s Quality : Ensure the quality of our products to ensure patient safety and achieve our mission of “Saving and Sustaining Lives”.  This can be achieved through: +++following Good Manufacturing Practices (GMP) +++ adhering to all quality procedures completing training on-time Doing it Right the First Time, and reporting any quality concerns immediately. As part of the plant’s   Enterprise Management System (EMS ), all employees must embrace a culture of Continuous Improvement by: participating in improvement activities identifying and implementing continuous improvement ideas participating in Tier meetings recognizing your peers, and embracing 6s. identifying and implementing VIP’s (Value Improvement Project) embrace continuous learning utilize Leader Standard Work utilize Root Cause Analysis tools to identify and prevent problems from recurring and drive measurable results.

Ensure validation packages for equipment, processes, computer systems and test methods are created in a timely manner and such packages demonstrate a validated state of control Author and coordinate validation protocols, manage the execution of validation testing plans by liaising with other departments to coordinate validation activities, compile and analyze data, perform statistical analysis and prepare validation packages Coordinate validation and IQ/OQ/PQ activities with Production, Engineering, Quality Control Laboratories and outside contractors providing leadership, training and guidance Participate in any technical discussions regarding process validation, equipment qualification, and computer system validation. Assist other business functions with the: Investigational studies, Commissioning protocols, Technical Position Papers, NCR investigations Participate as