Overview

Quality Engineer IIIAs part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.Location: On-site Santa Clara, CA. Relocation assistance is NOT provided.Our Santa Clara, CA site is a center for the design, development and manufacturing of innovative bioprocessing equipment and automation solutions that support the production of biologic medicines and vaccines. Our technologiesincluding single-use bioreactors, mixers, fermenters, chromatography systems, centrifuges and process control softwarehelp biopharmaceutical manufacturers improve efficiency, scale production and accelerate the delivery of life-changing therapies. By combining engineering innovation, manufacturing excellence and a commitment to quality, our teams help customers around the world bring breakthrough medicines to patients while advancing Thermo Fisher Scientific's mission of making the world healthier, cleaner and safer.How You Will Make an Impact:The Quality Engineer III provides quality engineering support for bioprocessing equipment automation products, manufacturing and quality systems, ensuring products and processes consistently meet customer, regulatory, and business requirements. This role drives business performance by leading quality investigations, managing quality system processes, reducing risk, and implementing continuous improvement initiatives that enhance product quality, compliance, and operational efficiency. The position ensures compliance with GMP, ISO, and applicable regulatory standards while maintaining ownership of site quality processes and supporting audit readiness across the business.Day In The Life:Quality Systems ManagementLead and manage CAPA, deviation, nonconformance, and change control activities.Review quality records to ensure timely investigation, root cause determination, and effective corrective actions.Facilitate and document risk assessments using FMEA and other risk management methodologies.Ensure compliance with document control and quality system requirements.Monitor quality system metrics and support continuous improvement initiatives.Investigation & Compliance SupportLead investigations related to product, process, supplier, and customer quality issues.Perform root cause analysis using structured problem-solving methodologies.Support validation and qualification activities to ensure compliance with quality and regulatory requirements.Participate in internal audits, customer audits, and regulatory inspections.Support supplier quality activities including qualification, issue resolution, and corrective action effectiveness reviews.Assist in the development and implementation of corrective and preventive actions.Continuous Improvement & Risk ManagementAnalyze quality data and trends to identify improvement opportunities.Lead or participate in continuous improvement projects to enhance product quality and process performance.Evaluate quality risks associated with products, processes, and changes.Support implementation of preventive quality strategies and best practices.Drive initiatives that improve compliance, efficiency, and customer satisfaction.Cross-Functional Collaboration & Customer SupportPartner with Manufacturing, Engineering, Validation, Supply Chain, and Regulatory Affairs teams to resolve quality issues.Provide quality guidance and support for equipment, automation system, process, and product changes throughout the product lifecycle.Support customer inquiries, complaint investigations, and supplier quality ac