Hiring: Principal Quality Engineer Company: Baxter International Inc. Location: St Paul, MN Job Posted Time: 2026-09-10 13:40:07 Target Skills & Keywords : Product Lifecycle Management, R, Regulatory Compliance, Risk Management, Six Sigma About the job Experience: •5-8 years of Quality Engineering experience within a medical device, biologics, pharmaceutical, combination product, or similarly regulated industry. •8 years of Quality Engineering experience within a medical device, biologics, pharmaceutical, combination product, or similarly regulated industry. Required Skills: •Here, you will find more than just a job—you will find purpose and pride. •As a Principal Quality Engineer, you will serve as a senior technical leader within the Quality organization, providing strategic quality engineering direction for complex manufacturing processes, product lifecycle management activities, new product development, and continuous improvement initiatives. •Apply advanced engineering and quality principles to solve highly complex technical and compliance challenges while influencing business decisions across functions. •Lead high-impact quality initiatives that support business objectives, regulatory requirements, and customer expectations while mentoring engineers and quality professionals throughout the organization. •Lead strategic projects and complex multi-functional initiatives with responsibility for planning, execution, risk management, stakeholder alignment, and achievement of business objectives. Qualifications: •Bachelor's degree in Engineering, Science, or a related technical field. •Demonstrated experience providing technical leadership for complex quality and compliance initiatives. •Extensive knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 14971, cGMP requirements, validation requirements, and risk management principles. •Advanced experience with CAPA, Nonconformance Management, Change Control, Supplier Quality, Complaint Handling, Auditing, Validation, and Design Controls. •Demonstrated ability to lead and influence multi-functional teams and senior stakeholders. •Strong analytical, statistical, and problem-solving skills with a proven track record of implementing effective corrective and preventive actions. •Demonstrated capacity to assess complex risks and make sound quality decisions balancing compliance, patient safety, business needs, and product requirements. •Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time. •US Benefits at Baxter (except for Puerto Rico) Compensation: •$112,000 - $154,000 / year •This position may also be eligible for discretionary bonuses Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!