Senior Quality Engineer

• ◆Use investigative tools to perform investigations and root cause analysis for manufacturing and R&D projects and quality processes, driving effective resolution and supporting long-term quality improvements.
• ◆Perform FMEA analysis, RCA, Gauge R&R studies, statistical evaluation, and process control activities to resolve quality and reliability concerns while proactively preventing future issues.
• ◆Monitor metrology and calibration activities to ensure quality objectives are met and that effective procedures and work instructions are in place to support operational excellence.
• ◆Prepare quality and inspection plans, procedures, instructions, and product and raw material specifications that support consistent product quality and manufacturing performance.
• ◆Perform testing, validation, equipment qualifications, and data analysis. Recommend improvements to equipment, products, and test methods based on technical findings and business needs.
• ◆Review manufacturing planning to ensure appropriate quality

are incorporated and potential risks are identified early.

• ✓Prepare documentation for critical quality control points throughout manufacturing processes, ensuring clear criteria and

for effective inspection and testing.

• ✓Compile and analyze data related to quality and manufacturing issues, initiate CAPA activities, and monitor the completion and effectiveness of corrective actions to drive sustained improvements.
• ✓Perform investigations and prepare reports for customer complaints, helping ensure timely resolution and a positive customer experience.
• ✓Conduct or participate in ISO, internal, and customer audits, contributing to a culture of quality, accountability, and continuous improvement.
• ✓Prepare and review Quality Technical Agreements and supplier evaluation surveys, fostering strong quality partnerships with suppliers and external stakeholders.
• ✓Support process and product improvement projects, product design reviews, and nonconformance investigations, helping drive quality improvements across the product lifecycle.
• ✓Perform ISO, GDP, and technical training to promote quality awareness, knowledge sharing, and best practices across the organization.
• ✓Build and maintain effective working relationships at all organizational levels, including customers and suppliers, to support quality and business objectives.
• ✓Serve as a trusted quality liaison with Engineering, Manufacturing, Marketing, and customers, helping align priorities and drive successful outcomes.
• ✓May serve as Lab Safety Coordinator in conjunction with the company's Hazard Communication Program.
• ✓Demonstrated ability to leverage AI-enabled and digital tools to improve efficiency, enhance decision-making, and support continuous improvement initiatives.

• ✓Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• ✓7+ years of Quality Engineering and/or Manufacturing Engineering experience within a regulated manufacturing environment.
• ✓Working knowledge of quality systems and regulatory requirements.
• ✓Experience with investigative and problem-solving methodologies, root cause analysis, CAPA, quality planning, auditing, and statistical data analysis.
• ✓Strong technical aptitude with the ability to evaluate quality requirements, analyze data, and interpret technical information.
• ✓Experience performing scientific and technical investigations, validation activities, and process improvement initiatives.
• ✓Excellent verbal, written, and interpersonal communication skills, with the ability to effectively communicate across technical and non-technical audiences.
• ✓Proficiency with Microsoft Office applications and other computer-based tools, including spreadsheets, databases, and flowcharting software.
• ✓Experience with MasterControl or similar electronic Quality Management Systems (eQMS) is preferred.
• ✓Experience supporting filtration products, single-use technologies, medical devices, biologics, pharmaceutical manufacturing, or other regulated industries is preferred.
• ✓ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Lead Auditor certification, or related quality certifications are a plus.
• ✓Ability to work in both office and manufacturing/laboratory environments, including periods of sitting, standing, walking, and lifting up to 25 pounds.

Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated base salary range for this role, based in the United States of America is $115,000-$155,000. Compensation decisions are dependent on several