Sr. Quality Engineer

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 As a member of the Quality Engineering team in St. Paul, you will leverage standard engineering principles to resolve difficult problems, from conception to final design with team input. This team performs standard engineering work requiring application of standard engineering techniques, procedures and criteria. This role is responsible for ensuring that the quality of all product/process design meet all customer requirements and are manufacturable at the time of transfer to Manufacturing/Operations under the guidance of senior personnel. You will help to perform engineering design evaluations and may develop a range of products including Biologic and non-biologic. On occasion, you may recommend alterations to development and design to improve quality of products and/or procedures.

When you join the Quality team you belong to a group that never shies away from a challenge and truly believes that teamwork makes jobs great. Motivated by work that is never the same from one day to the next, this team powers through internal processes to create products that they deeply believe in. Individuals within the quality organization are encouraged to think strategically about how to best-solve any issues at hand. Baxter remains positive, confident, and resilient as it approaches new challenges and strives to create the best possible product for the client, always.

Provide quality engineering support to manufacturing operations, including nonconformance investigations, CAPA activities, change control assessments, validation reviews, and production issue resolution. May lead and/or facilitate investigations of nonconforming product, customer complaints, process deviations, and quality system events using appropriate root cause analysis methodologies. Evaluate and approve quality-related documentation including change orders, validations, specifications, work instructions, protocols, reports, and risk management files. Support product development and sustaining engineering projects by ensuring quality and regulatory requirements are incorporated into design and process development activities. Collaborate with cross-functional teams to develop and maintain risk analyses, inspection plans, acceptance criteria, and control strategies. Support process validation, equipment qualification, test method validation, and software validation activities, ensuring compliance with applicable regulatory requirements. Develop and analyze quality KPIs and metrics to identify trends, risks, and opportunities for continuous improvement. Partner with supplier quality and procurement teams to evaluate supplier performance, investigate supplier-related quality issues, and support supplier qualifications and audits. Participate in internal audits, customer audits, and regulatory inspections. Serve as a quality representative on cross-functional project teams and provide guidance on quality system and regulatory requirements. Support Management Review, Quality Planning, and Continuous Improvement initiatives as assigned. Participate in Change Control Board, CAPA Review Board, MRB, Management Review, and risk governance forums.  May lead forum