Sr Quality Engineer

Essential Duties and Responsibilities

• 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.

Qualifications

Bachelor's degree in Engineering or a related technical discipline required.

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.