Baxter International Inc.
Sr Manager, Design Quality
Baxter International Inc., Round Lake, Illinois, United States, 60073
Sr Manager, Design Quality
Baxter International Inc.
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. 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.
Your 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.
What you will be doing 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
What do you bring
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
Compensation: Base salary range $136,000 to $187,000, plus an annual incentive bonus, commission target, and equity target. Actual salary may vary based on skills, experience, and location.
Benefits: Medical and dental coverage starting day one; life, accident, short-term and long-term disability; business travel accident insurance; Employee Stock Purchase Plan; 401(k) with matching; Flexible Spending Accounts; educational assistance; paid holidays; paid time off; parental leave; commuting benefits; Employee Discount Program; Employee Assistance Program; childcare benefits.
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.
#J-18808-Ljbffr
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. 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.
Your 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.
What you will be doing 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
What do you bring
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
Compensation: Base salary range $136,000 to $187,000, plus an annual incentive bonus, commission target, and equity target. Actual salary may vary based on skills, experience, and location.
Benefits: Medical and dental coverage starting day one; life, accident, short-term and long-term disability; business travel accident insurance; Employee Stock Purchase Plan; 401(k) with matching; Flexible Spending Accounts; educational assistance; paid holidays; paid time off; parental leave; commuting benefits; Employee Discount Program; Employee Assistance Program; childcare benefits.
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.
#J-18808-Ljbffr