Sr Manager, Design Quality

Baxter • Round Lake, IL

21d • $136,000 - $187,000

About The Position

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. You role at Baxter The Sr. Manager, Design Quality will individually contribute and manage through team members the activities within the Round Lake Infusion Pump New Product Development (NPD) and post market support Design Quality team. This role is responsible for results in terms of compliance and conformance to regulations and Baxter Quality policies.

Requirements

• BS in science or engineering.
• 8+ years of experience in Quality, Manufacturing, R&D Engineering or related field.
• 3+ years in a supervisory or leadership role managing quality engineers
• Experience with electromechanical devices strongly preferred
• Thorough knowledge of applicable procedures, specifications, regulations and standards related to Medical Device product development and post market support.
• Proven experience interacting with regulators and leading inspections or audits
• Strong analytical, problem-solving, and decision-making capability
• Excellent verbal and written communication, influencing, negotiation, and stakeholder engagement
• Project management skills: ability to drive multiple concurrent projects with cross-functional teams

Nice To Haves

• Experience with electromechanical devices strongly preferred

Responsibilities

• Team leadership & development Lead, coach, mentor, and develop a team of quality / design quality engineers and specialists Allocate resources, set goals, conduct performance reviews, build bench strength
• Design Quality & Lifecycle Oversight Provide oversight and input across all stages of product development: design inputs, design reviews, verification/validation, risk management, design transfer Ensure seamless design to manufacture transitions, including plans, protocols, acceptance criteria, and training
• Post-Market Quality & Field Support Lead root cause analysis, CAPA, complaint handling, trend analysis, corrective & preventive actions Partner with field service / support teams to triage and resolve product anomalies Monitor post-market metrics and lead improvement initiatives
• Regulatory Compliance & Inspection Readiness Ensure conformance to FDA QSR / 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, and other global standards Serve as the quality SME during regulatory audits / inspections; lead responses and corrective plans Support internal audits, supplier audits, and third-party assessments
• Cross-Functional Collaboration & Influence Act as the primary quality liaison to R&D, systems, manufacturing, supplier quality, regulatory, and service Influence roadmaps, design tradeoffs, and project schedules to embed quality early

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees