Quality Engineering Senior

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. 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. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

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.

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.

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

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) based on the Class level for each Clean Room.
Minimal travel as needed

Ability to sit or stand for minimum of 8 hours, with breaks provided throughout the shift
We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. This position may also be eligible for discretionary bonuses. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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