Engineer III, QA

Job description

Work Schedule Standard Office Hours (40/wk) Environmental Conditions Office Job Description As 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. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. 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 technologies—including single-use bioreactors, mixers, fermenters, chromatography systems, centrifuges and process control software—help 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 Management Lead 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 Support Lead 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 Management Analyze 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 Support Partner 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 activities. Communicate quality risks, trends, and recommendations to stakeholders. Promote a culture of quality, compliance, and continuous improvement across the organization. Perform other duties and responsibilities as assigned to support business objectives, quality initiatives, and operational requirements. Education & Experience: Required: Advanced degree in Engineering, Life Sciences, Biotechnology or related field with 3 years of experience in quality assurance, quality engineering, or quality systems within a regulated industry such as biotechnology, pharmaceutical, medical device, life sciences, or related manufacturing environments OR Bachelor's degree in Engineering, Life Sciences, Chemistry, Biotechnology or related field with 5 years of experience in quality assurance, quality engineering, or quality systems within a regulated industry such as biotechnology, pharmaceutical, medical device, life sciences, or related manufacturing environments. Experience managing CAPA, deviations, nonconformances, change controls, and quality investigations. Experience conducting root cause analysis and implementing corrective and preventive actions. Experience supporting GMP and/or ISO-compliant quality management systems. Experience working cross-functionally with Manufacturing, Engineering, Validation, and Supply Chain teams. Preferred: ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent quality certification. Formal training in GMP, ISO 9001, ISO 13485, risk management, or quality systems. Experience within bioprocessing, automation systems, single-use technologies, life sciences equipment, or related regulated manufacturing environments. Experience supporting customer audits, regulatory inspections, and supplier quality activities. Experience with validation and qualification protocols. Experience leading continuous improvement and risk management initiatives. Experience utilizing electronic quality management systems (eQMS). Knowledge, Skills, Abilities: Required: Strong knowledge of GMP, GDP, ISO 9001, and applicable regulatory requirements; familiarity with ISO 13485 is preferred. Expertise in quality systems including CAPA, deviation management, change control, document control, and risk management. Strong understanding of root cause analysis methodologies and problem-solving tools. Knowledge of validation, qualification, and quality risk management principles. Ability to conduct risk assessments using FMEA and related methodologies. Strong analytical skills with the ability to interpret quality data, identify trends, and recommend improvements. Excellent written and verbal communication skills for interaction with internal stakeholders, customers, auditors, and regulatory agencies. Strong project management and organizational skills with the ability to manage multiple priorities. Ability to work independently while collaborating effectively within cross-functional teams. Proficiency with Microsoft Office applications including Excel, Word, PowerPoint, and data analysis tools. Experience using electronic Quality Management Systems (eQMS) such as TrackWise, MasterControl, or equivalent. Strong attention to detail while maintaining a broad business perspective. Preferred: Knowledge of bioprocessing equipment, automation systems, and single-use technology products. Experience with statistical analysis techniques and quality tools. Familiarity with ERP systems such as SAP. Experience with data visualization and reporting tools such as Power BI. Additional language proficiency to support global customer and supplier interactions. Physical Requirements and Work Environment: Combination of office-based work and manufacturing fl