This is whereyour work makes a difference.
At Baxter, we are deeply connected by our mission. No matter your role, your work has a positive impact on people around the world. As a Senior Quality Engineer, you will provide technical leadership and quality engineering expertise to support manufacturing operations, drive continuous improvement, and ensure compliance with applicable regulatory and quality system requirements.
This role is responsible for leading validation activities, process improvement initiatives, risk management efforts, and quality engineering projects that enhance product quality, manufacturing efficiency, and operational excellence. The Senior Quality Engineer serves as a key cross-functional partner, collaborating with Manufacturing, Engineering, Quality, Regulatory Affairs, and other stakeholders to develop and implement sustainable solutions that support Baxters commitment to delivering safe, high-quality products to patients.
Essential Duties and ResponsibilitiesThe essential functions of this position include, but are not limited to:
- Lead and support the development, implementation, qualification, and validation of new manufacturing equipment, processes, and systems, as well as improvements to existing operations.
- Own and execute validation activities, including protocol development, risk assessments, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Partner with Manufacturing, Engineering, Quality, Regulatory Affairs, and Corporate functions to ensure successful project execution and compliance with organizational standards.
- Drive quality and process improvement initiatives utilizing data-driven decision-making, statistical analysis, and continuous improvement methodologies.
- Manage and support capital and operational improvement projects, including planning, execution, validation, implementation, and cost management.
- Provide statistical expertise and technical support for process validations, product validations, and ongoing process monitoring activities.
- Develop and evaluate sampling plans, test methods, and validation strategies to ensure product and process effectiveness.
- Conduct risk assessments and support mitigation activities related to product quality, manufacturing processes, and quality systems.
- Author and review validation protocols, reports, technical studies, investigations, and other quality documentation.
- Lead validation efforts associated with equipment installations, process transfers, process changes, and continuous improvement initiatives.
- Support investigations related to customer complaints, nonconformances, quality events, and product-related concerns.
- Evaluate and assess supplier product and process changes to ensure continued compliance and product quality.
- Ensure manufacturing and quality operations comply with Baxter Quality System requirements, Good Manufacturing Practices (GMP), regulatory requirements, and applicable corporate standards.
- Apply engineering principles, statistical techniques, and Lean/Six Sigma methodologies to identify opportunities for process optimization and defect prevention.
- Support and lead Corrective and Preventive Action (CAPA) investigations, root cause analyses, and effectiveness verification activities.
- Demonstrate strong technical writing skills through the development of investigations, CAPAs, validation documentation, and quality system records.
- Proactively identify and implement actions that prevent nonconformities and improve product, process, and quality system performance.
- Support inspection readiness and participate in internal, customer, and regulatory audits as required.
QualificationsEducation- Bachelor's degree in Engineering or a related technical discipline required.
Experience- Minimum of 5 years of experience in a manufacturing, quality engineering, or regulated industry environment preferred.
- Experience supporting validation programs, process improvement initiatives, and quality systems within a regulated manufacturing environment preferred.
- Experience with medical device, pharmaceutical, biotechnology, or other FDA-regulated industries is preferred.
Knowledge, Skills, and Abilities- Strong understanding of validation principles, risk management methodologies, and quality engineering practices.
- Working knowledge of Good Manufacturing Practices (GMP), quality system regulations, and applicable industry standards.
- Demonstrated ability to perform technical investigations and lead root cause analysis activities.
- Experience utilizing statistical analysis tools and continuous improvement methodologies, including Lean and Six Sigma principles.
- Strong project management, organizational, and problem-solving skills.
- Excellent technical writing, verbal communication, and cross-functional collaboration skills.
- Proficiency with Microsoft Office Suite, including Word, Excel, Outlook, and PowerPoint.
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 employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $96,000 annually. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based upon location, skills and expertise, experience, and other relevant factors. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
Applicants must be authorized to work for any employer in the U.S. We cannot sponsor or transfer sponsorship of an employment visa.
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 employees.For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site:
