Principal Quality Engineer

About the role

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.

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.

Responsibilities

• 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.

Requirements

• 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.

Pay

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.

Benefits

• Medical and dental coverage starting on day one.
• Basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Employee Stock Purchase Plan (ESPP) with discounted company stock purchases.
• 401(k) Retirement Savings Plan (RSP) with employee contributions and company matching.
• Flexible Spending Accounts and educational assistance programs.
• 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.
• Commuter benefits, Employee Discount Program, Employee Assistance Program (EAP), and childcare benefits.