Sr. Quality Engineer

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.

• 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 meetings as required.
• Assist in the development and maintenance of quality system procedures, work instructions, and training materials.
• Apply statistical methods and quality tools to evaluate process capability, product quality, and process performance.
• Sustain a clean and safe work environment using 6S principles.
• Learn, understand, and apply quality standards, Standard Operating Procedures (SOPs), ISO 13485 requirements, and Current Good Manufacturing Practices (cGMP).
• Complete training requirements in a timely manner.
• Maintain reliable attendance.
• Contribute to a positive work environment.
• Perform other duties as assigned.

• Bachelor's degree in Engineering or Science (Biomedical Engineering, Quality Engineering, Chemical Engineering, Mechanical Engineering, Materials Science, Biology, Chemistry, Biochemistry, or related discipline).
• Minimum 3 years of Quality Engineering experience within a regulated medical device, pharmaceutical, biologics, or combination product environment.
• Working knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, risk management principles (ISO 14971), and validation requirements.
• Experience with CAPA, Nonconformance Management, Complaint Handling, Auditing, Supplier Quality, and Change Control processes.
• Ability to communicate technical and quality-related issues effectively, both verbally and in writing.
• Strong understanding of quality systems and regulatory requirements applicable to medical devices, including ISO 13485, FDA Quality System Regulation (QSR), and cGMP requirements.
• Ability to work collaboratively within cross-functional teams.
• Ability to mentor Quality Engineers and quality professionals.
• Serve as subject matter expert and technical leader.
• Strong analytical and problem-solving skills with demonstrated experience in root cause analysis and corrective action implementation.
• Ability to assess risk and make sound quality decisions based on data and compliance requirements.
• Strong technical writing and documentation review skills.
• Professional certifications such as ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent are preferred.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $96,000 - $132,000 annually. The estimated salary is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

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.

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. 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. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

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.