Senior Quality Engineer – Remote Validation & Compliance Specialist for Medical Device & Pharmaceutical Manufacturing
Join Baxter: Where Every Day You Help Save and Sustain Lives
About Baxter – For more than 85 years, Baxter has been a global leader in delivering innovative medical products and therapies that improve the health and well‑being of patients worldwide. From life‑saving infusion solutions and renal therapies to advanced biosurgery devices, Baxter’s portfolio touches nearly every hospital, clinic, and home around the globe. Our mission—to save and sustain life—is more than a tagline; it is a promise that guides every decision, every process, and every employee. As a member of our Quality organization, you will be at the heart of this mission, ensuring that the highest standards of safety, efficacy, and regulatory compliance are embedded in every product that leaves our facilities.
Why This Role Is Unique
We are seeking a Senior Quality Engineer who thrives in a fast‑paced, highly regulated environment and is excited about the opportunity to lead validation projects that directly impact patient safety. This is a fully remote position, allowing you to work from anywhere while partnering with cross‑functional teams across multiple Baxter sites. You will apply your expertise to a broad portfolio of systems—including automated visual inspection equipment, analytical laboratory instruments, manufacturing automation, and water‑for‑injection (WFI) processes—ensuring they meet FDA expectations and industry best practices.
Key Responsibilities
As a senior member of the Quality team, you will take ownership of a wide range of validation and compliance activities:
- Lead System Validation: Design, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for critical manufacturing and laboratory equipment.
- Regulatory Alignment: Ensure all validation activities comply with the 2011 FDA Guidance for Process Validation, USP <1790> Visual Inspection of Parenterals, and other applicable regulations.
- Process Capability & Control: Perform statistical analyses, capability studies, and ongoing process control assessments to confirm that processes remain within defined specifications.
- Cross‑Functional Collaboration: Partner with Manufacturing, Quality Control, Engineering, and IT teams to introduce new technologies, troubleshoot issues, and drive continuous improvement.
- Documentation Excellence: Write clear, concise validation protocols, test plans, and reports; maintain Master Validation Files (MVFs) that stand up to rigorous audit scrutiny.
- Training & Knowledge Transfer: Develop and deliver training materials for system users, validation personnel, and auditors, fostering a culture of quality awareness.
- Project Management: Lead medium‑to‑large scale validation projects, develop detailed work plans, track milestones, and report status to senior leadership.
- Software & Computer System Validation (CSV): Validate software-driven control systems, ensuring they meet ALCOA‑plus data integrity requirements and follow a defined software life‑cycle process.
- Risk Assessment: Conduct Failure Mode and Effects Analyses (FMEA) and risk assessments to anticipate potential quality gaps and implement mitigation strategies.
- Continuous Improvement: Identify opportunities to streamline validation procedures, reduce cycle times, and improve data integrity across the enterprise.
Essential Qualifications
- Education: Bachelor’s degree in Engineering (Mechanical, Industrial, Chemical, Biomedical, Electrical, or Computer Engineering) or a related scientific discipline.
- Experience: Minimum of 3 years of hands‑on validation experience within the pharmaceutical, biotech, or medical device industry.
- Regulatory Knowledge: Demonstrated familiarity with FDA regulations, GMP, USP <1790>, and industry guidance on process validation and CSV.
- Technical Skills: Proven ability to develop and execute IQ/OQ/PQ protocols, perform statistical analyses, and use validation software tools.
- Soft Skills: Critical thinker, strong communicator (both written and verbal), self‑starter, collaborative team player with a sense of urgency and solution‑oriented mindset.
- Software Proficiency: Advanced Microsoft Office (Word, Excel, PowerPoint, Outlook, Project) and familiarity with data‑collection platforms; exposure to Wonderware, Allen‑Bradley PLCs, or similar is a plus.
- Physical Requirements: Ability to perform typical manufacturing site activities such as lifting up to 20 lb, squatting, climbing, and reaching, as well as maintaining visual acuity for color‑discrimination tasks.
Preferred Qualifications & Desirable Experience
- Master’s degree in a relevant engineering or science field.
- Additional 2+ years of experience in Quality Assurance, Regulatory Affairs, or Compliance roles.
- Hands‑on experience with Automated Visual Inspection Systems (AVIS) or Robotics Automation.
- Experience in Water‑for‑Injection (WFI) system qualification or Cleanroom validation.
- Familiarity with statistical software (e.g., Minitab, JMP) for capability and process control analysis.
- Certifications such as ASQ Certified Quality Engineer (CQE) or Certified Software Quality Engineer (CSQE).
Core Competencies for Success
- Analytical Acumen: Ability to interpret complex data sets, identify trends, and draw actionable conclusions.
- Regulatory Savvy: Keen understanding of how regulatory expectations translate into practical validation activities.
- Project Leadership: Skillful at managing timelines, resources, and stakeholder expectations across geographically dispersed teams.
- Collaboration: Effective at building relationships with engineering, manufacturing, IT, and quality teams to achieve shared goals.
- Adaptability: Comfortable working in a dynamic environment where priorities shift to meet urgent manufacturing schedules or product launches.
- Quality Mindset: Commitment to “quality first” philosophy, even when it requires challenging trade‑offs or advocating for additional resources.
Career Growth & Learning Opportunities
At Baxter, your professional development is a strategic priority. As a Senior Quality Engineer, you will have access to:
- Mentorship Programs: Pairing with senior leaders in Quality and Regulatory Affairs to accelerate skill development.
- Continuous Education: Tuition reimbursement for advanced degrees, certifications, and specialized training (e.g., GAMP, Six Sigma, Lean).
- Global Exposure: Opportunities to work on multi‑site projects, travel to manufacturing sites, and participate in international regulatory hearings.
- Leadership Pathways: Clear progression routes toward Principal Engineer, Quality Manager, or Director‑level roles.
- Innovation Hubs: Involvement in Baxter’s Digital Transformation initiatives, including AI‑driven analytics and advanced automation validation.
Work Environment & Culture
Baxter’s culture is built around purpose, inclusion, and empowerment. As a remote employee, you will enjoy:
- Flexibility: Work from any location with secure, company‑provided collaboration tools.
- Inclusive Community: Employee resource groups, diversity councils, and a commitment to equitable pay.
- Safety‑First Mindset: Robust health, safety, and wellness programs that protect you and your family.
- Team Spirit: Regular virtual town halls, cross‑functional webinars, and recognition programs that celebrate achievements.
Compensation, Perks & Benefits
We recognize that great talent deserves great rewards. While specific numbers will be discussed during the interview process, the overall package includes:
- Competitive Salary Range: $60,000 – $132,000, commensurate with experience, expertise, and geographic considerations.
- Annual Incentive Bonus: Performance‑based bonus that reflects individual and company success.
- Health & Wellness: Medical, dental, and vision coverage for you and eligible dependents.
- Retirement Planning: 401(k) plan with company match and an Employee Stock Purchase Program.
- Paid Time Off: 160 hours of PTO annually, plus paid holidays, parental leave, and flexible scheduling.
- Professional Development: Tuition reimbursement, certification support, and access to online learning platforms.
- Work‑Life Balance: Remote work flexibility, wellness resources, and programs to help you thrive both personally and professionally.
Diversity, Equity & Inclusion Commitment
Baxter is proud to be an equal‑opportunity employer. We evaluate all applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity, veteran status, disability, or any other protected characteristic. We also provide reasonable accommodations throughout the hiring process. If you need assistance, simply let us know, and we will work with you to ensure a smooth experience.
Application Process & Next Steps
If you are ready to bring your validation expertise to a purpose‑driven organization where quality truly matters, we encourage you to apply today. Please submit your updated résumé and a cover letter detailing how your experience aligns with the responsibilities outlined above.
Our recruiting team will review applications on an ongoing basis and contact qualified candidates for a virtual interview. We look forward to learning how you can help Baxter continue to save and sustain lives worldwide.
Take the Leap – Join Baxter’s Quality Team
Transform your career while making a tangible difference in patients’ lives. Apply now and become part of a legacy of innovation, compassion, and unwavering commitment to quality.
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