Principal Quality Engineer

Baxter • St Paul, MN

1d

About The Position

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.

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.

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.

Benefits

• medical and dental coverage that start on day one
• insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan (ESPP)
• 401(k) Retirement Savings Plan (RSP)
• Flexible Spending Accounts
• 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
• paid parental leave
• commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• childcare benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Principal