Sr Manager, Design Quality at Baxter International

Round Lake, Illinois, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

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
Applicants must be authorized to work for any employer

Responsibilities

Lead, coach, mentor, and develop a team of quality / design quality engineers and specialists
Allocate resources, set goals, conduct performance reviews, build bench strength
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
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
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
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

Skills

Key technologies and capabilities for this role

Design InputsDesign ReviewsVerificationValidationRisk ManagementDesign TransferRoot Cause AnalysisCAPAComplaint HandlingTrend AnalysisRegulatory ComplianceTeam Leadership

Questions & Answers

Common questions about this position

What qualifications are required for the Sr Manager, Design Quality role?

Candidates need a BS in science or engineering, 8+ years of experience in Quality, Manufacturing, R&D Engineering or related field, and 3+ years in a supervisory or leadership role managing quality engineers. Experience with electromechanical devices is strongly preferred, along with thorough knowledge of medical device regulations and standards.

What is the salary or compensation for this position?

This information is not specified in the job description.

Is this a remote position, or is there a required location?

This information is not specified in the job description.

What is the company culture like at Baxter?

Baxter colleagues are united by a mission to Save and Sustain Lives, driven by a culture of courage, trust, and collaboration, where every individual is empowered to take ownership and make a meaningful impact.

What experience makes a strong candidate for this role?

Strong candidates will have supervisory experience managing quality engineers, hands-on knowledge of medical device regulations like FDA QSR, ISO 13485, and ISO 14971, and proven experience with electromechanical devices and post-market support.

Baxter International

Provides essential medical products and services

About Baxter International

Baxter International provides a wide range of medical products and services essential for healthcare. The company operates in several areas, including critical care, hospital care, nutritional care, renal care, and surgical care. Its products are used in various settings, from emergency rooms to home healthcare, helping to meet the needs of patients and healthcare professionals. Baxter develops, manufactures, and distributes medical devices, pharmaceuticals, and biotechnology products, generating revenue through sales to healthcare providers and institutions. A key aspect that sets Baxter apart from competitors is its recent acquisition of Hillrom, which enhances its ability to offer comprehensive healthcare solutions. The company's goal is to improve care outcomes and increase access to healthcare through continuous innovation and a focus on patient needs.

Deerfield, IllinoisHeadquarters

1931Year Founded

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Parental Leave

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Commuter Benefits

Mental Health Support

Risks

Needle-free injection technology could disrupt Baxter's traditional injection-based therapies.

Shift to home healthcare may require Baxter to adapt its product offerings.

Growing digital health importance necessitates further investment from Baxter to stay competitive.

Differentiation

Baxter's acquisition of Hillrom enhances its comprehensive healthcare solutions portfolio.

Strong focus on patient-centric innovation sets Baxter apart in the healthcare industry.

Baxter's partnerships, like with Ayogo, leverage digital health for improved patient outcomes.

Upsides

Baxter's investment in Medically Home aligns with the growing home healthcare market.

Rising demand for personalized medicine offers Baxter opportunities for targeted therapies.

Expansion in telehealth supports Baxter's integrated healthcare solutions strategy.

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