Principal Quality Engineer

Zvh; Saint Paul (MN); On-site; USD 112,000 - 154,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Employee Stock Purchase Plan (ESPP)

Paid time off

Job summary

Baxter is seeking a Principal Quality Engineer to provide strategic quality direction across complex manufacturing processes, product lifecycle management, and new product development. You will mentor engineers and shape risk management, design controls, supplier quality, and regulatory compliance activities.

You will lead investigations, drive CAPA and change controls, and act as the technical authority on validation, process controls, and quality systems.

Qualifications

• Bachelor's degree in Engineering, Science, or related field.
• 5-8 years of Quality Engineering in a regulated industry.
• Knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 14971, cGMP requirements, validation requirements, and risk management principles.

Responsibilities

• Lead Quality Engineering for complex manufacturing, sustaining engineering, new product development, and process improvement initiatives.
• Provide strategic quality leadership for production, process development, equipment implementation, technology transfers, and product lifecycle management.
• Lead investigations involving nonconforming product, customer complaints, CAPAs, audits, supplier issues, and deviations using advanced root cause methods.
• Act as technical authority for quality risk assessments, design transfer, process controls, validation strategies, and compliance decisions.
• Lead multi-functional teams to resolve significant product quality, manufacturing, supplier, and regulatory issues.

Skills

Quality leadership

FDA QSR knowledge

ISO 13485 knowledge

CAPA & Change Control

Injection molding expertise

Education

Bachelor's degree in Engineering/Science

Job description

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 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. You will apply advanced engineering and quality principles to solve highly complex technical and compliance challenges while influencing business decisions across functions. This role serves as a quality SME for product and process development, manufacturing operations, validation, risk management, design control, supplier quality, and regulatory compliance activities. You will lead high-impact quality initiatives that support business objectives, regulatory requirements, and customer expectations while mentoring engineers and quality professionals throughout the organization.

What You'll Be Doing

• Serve as the lead Quality Engineering representative for complex manufacturing, sustaining engineering, new product development, and process improvement initiatives.
• Provide strategic quality leadership for production, process development, equipment implementation, technology transfers, and product lifecycle management activities.
• Lead complex investigations involving nonconforming product, customer complaints, CAPAs, audit observations, supplier issues, and manufacturing deviations applying advanced root cause investigation methodologies.
• Act as the technical authority for quality risk assessments, design transfer activities, process controls, validation strategies, and compliance decision-making.
• Lead and facilitate multi-functional teams in the resolution of significant product quality, manufacturing, supplier, and regulatory compliance issues.
• Provide advanced quality engineering support associated with supplier manufacturing processes, such as, injection molding, including validation, process capability analysis, control strategies, tooling changes, process optimization, and continuous improvement initiatives.
• Establish and maintain quality plans, risk management files, inspection strategies, acceptance criteria, statistical methods, and process monitoring systems.
• Review and approve complex quality system documentation including validation protocols and reports, change controls, specifications, risk analyses, engineering studies, design documentation, and technical assessments.
• Provide strategic oversight and guidance for process validation, equipment qualification, software validation, test method validation, and continuing process verification activities.
• Support and/or contribute to Management Review, CAPA Review Board, Change Control Board, Material Review Board, and other quality governance forums.
• Represent Quality during regulatory inspections, customer audits, notified body assessments, and corporate audits.
• Lead internal audit programs and serve as a Lead Auditor supporting compliance to FDA QSR, ISO 13485, MDSAP, and other applicable regulatory requirements.
• Partner with Supplier Quality teams on supplier qualification, supplier performance management, audits, and supplier development activities.
• Drive quality system improvements through data analysis, KPI development, trend monitoring, risk identification, and Lean Six Sigma methodologies.
• Serve as mentor and technical coach to Quality Engineers and multi-functional personnel.
• Provide quality leadership and influence without direct authority across Operations, Engineering, Regulatory Affairs, R&D, Supply Chain, and Commercial organizations.
• Lead strategic projects and complex multi-functional initiatives with responsibility for planning, execution, risk management, stakeholder alignment, and achievement of business objectives.

What You'll Bring

• Bachelor's degree in Engineering, Science, or a related technical field.
• 5-8 years of Quality Engineering experience within a medical device, biologics, pharmaceutical, combination product, or similarly regulated industry.
• 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.
• Experience supporting and improving injection molding manufacturing processes within a regulated environment.
• 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.
• Ability to assess complex risks and make sound quality decisions balancing compliance, patient safety, business needs, and product requirements.

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 $112,000 - $154,000 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.

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)

• 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.

Equal Employment Opportunity

Baxter is an equal opportunity employer. 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.

Know Your Rights: Workplace Discrimination is Illegal. Reasonable Accommodations 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.

No matter your role at Baxter, your talent, skills, and time has a direct impact on people's lives. Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we're more determined than ever to make a lasting impact as we are redefining healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.