Sr Quality Engineer

About this role

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 use 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.

What You'll Be Doing

• Provide Quality Engineering support to manufacturing operations, including nonconformance investigations, CAPA activities, change control assessments, validation reviews, and production issue resolution.

• Lead and facilitate investigations of nonconforming product, customer complaints, process deviations, supplier-related quality issues, and quality system events using appropriate root cause analysis methodologies.

• Act as a quality representative on cross-functional teams supporting manufacturing, product development, process improvement, validation, and sustaining engineering activities.

• Provide quality engineering support associated with supplier manufacturing processes such as injection molding, including process validation, process capability analysis, tooling changes, process monitoring, and continuous improvement initiatives.

• Evaluate and approve quality-related documentation including change controls, validations, protocols, reports, specifications, procedures, risk assessments, and engineering studies.

• Collaborate with Manufacturing Engineering, R&D, Regulatory Affairs, Operations, and Supply Chain teams to ensure quality and regulatory requirements are incorporated into products and processes.

• Lead risk management activities, including development and maintenance of risk analyses, inspection plans, acceptance criteria, and process control strategies.

• Support process validation, equipment qualification, software validation, and test method validation activities while ensuring compliance with applicable regulations and standards.

• Analyze quality metrics and performance data to identify trends, risks, and opportunities for continuous improvement.

• Support supplier qualification activities, supplier audits, supplier quality investigations, and supplier performance monitoring.

• Participate in internal audits, customer audits, regulatory inspections, and notified body assessments.

• Serve as a Lead Auditor for internal quality system audits and support audit readiness initiatives across the organization.

• Lead quality improvement and compliance projects from initiation through implementation, ensuring project objectives, timelines, are achieved.

• Mentor junior Quality Engineers and provide technical guidance to cross-functional stakeholders.

• Present technical and quality-related information to leadership teams, customers, auditors, suppliers, and multi-functional partners.

• Support Management Review, CAPA Review Board, Change Control Board, Material Review Board, and other quality governance forums.

What You'll Bring • Bachelor's degree in Engineering, Science, or a related technical field.

• Minimum 3 years of Quality Engineering experience within a regulated medical device, pharmaceutical, biologics, or combination product environment.

• Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 14971, cGMP requirements, and validation principles.

• Experience with CAPA, Nonconformance Management, Complaint Handling, Change Control, Supplier Quality, Auditing, and Validation processes.

• Demonstrated experience leading cross-functional investigations and quality improvement initiatives.

• Strong analytical, problem-solving, and risk-based decision-making skills.

• Experience supporting manufacturing processes in a regulated environment.

• Excellent presentation, facilitation, and interpersonal communication skills.

• Ability to effectively communicate complex technical, quality, and regulatory information to audiences at all organizational levels, from manufacturing personnel to executive leadership.

• Strong written and verbal communication skills with the ability to communicate clearly and professionally with internal stakeholders, customers, suppliers, regulatory agencies, and auditors.

• Demonstrated ability to influence multi-functional teams and build consensus in a matrix organization.

• Ability to mentor and develop quality professionals while serving as a technical resource within the organization.

Work Environment • This is an onsite position.

• Time will be divided between desk/office, production, laboratory, and warehouse areas. Some production areas will require occasional work in a clean room environment wearing special garments and PPE (e.g. scrubs, hair bonnets, frocks, hoods, masks, gloves, safety glasses) b

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