Sr Manager, Design Quality

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves 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 jobyou 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.

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

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 our employees and we strive to be more transparent with our pay practices. To that end this position has a base salary range of $136000 to $187000 plus an annual incentive bonus commission target and equity target. The above range represents the expected base salary range for this position. The actual salary may vary based upon several factors including but not limited to relevant skills/experience time in the role business line and geographic/office location.

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.

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US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. 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 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.

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