Manager, QA

Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
When you are part of the team at Thermo Fisher Scientific, you will do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you will be supported in achieving your career goals! At Thermo Fisher Scientific, each one of our 90,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer!
The Quality Engineering Manager provides leadership and technical direction for the Quality Engineering team, ensuring effective Quality support throughout the product and process lifecycle. This role is responsible for leading Quality Engineering activities supporting product and process design, new product introduction (NPI), risk management, nonconformances, deviations, CAPAs, complaints, and continuous improvement.
The Quality Engineering Manager partners closely with Engineering, Operations, R&D, Supply Chain and other functions to ensure quality and compliance requirements are incorporated into product and process decisions, risks are appropriately identified and controlled, and quality issues are resolved effectively and sustainably.
Reporting to the Senior Manager, Quality, this position is accountable for the performance, capability and development of the Quality Engineering team and plays a key role in strengthening a proactive, risk-based quality culture.
Location/Division Specific Information
Thermo Fisher Scientific is seeking a motivated candidate to join our Quality Assurance leadership team as Manager, Quality in Fremont, CA.
Key Responsibilities
Quality Engineering Leadership
Lead, coach, and develop the Quality Engineering team, establishing clear responsibilities, priorities, and performance expectations.
Manage day-to-day allocation of QE resources based on product, project, compliance, and business risk.
Build technical capability within the team through coaching, development planning, cross-training, and standardized Quality Engineering practices.
Establish and monitor Quality Engineering performance metrics and use data to identify risks, trends, and improvement opportunities.
Provide technical guidance and escalation support for complex or high-risk quality issues.
Promote a culture of accountability, collaboration, continuous improvement and quality ownership.
Establish procedures that simplify the process/workflow while maintaining a high level of compliance, including meeting documentation standards in relation to requirements of 21 CFR Part 820, ISO 13485, ISO 14971, IVDD, IVDR, and/or MDSAP.
Ensure all CAPAs, NCs, deviations, and complaints are implemented per company procedure and advise teams on how to effectively navigate and complete the process.
Drive regular inter-department and cross-functional review board meetings to ensure identified issues are being reviewed and addressed in a timely fashion in accordance with the company goals and regulatory requirements.
Design & New Product Introduction
Provide Quality Engineering leadership for product and process design, development, transfer (Design Controls and NPI activities.)
Partner with Engineering and other functions to ensure quality requirements and risk controls are incorporated early in product and process development.
Support design reviews, process reviews, qualification/validation activities, change implementation and manufacturing readiness.
Ensure Quality deliverables for NPI projects are defined, appropriately resourced and completed according to project requirements.
Identify potential product and process risks before implementation and drive appropriate mitigation strategies.
Risk Management
Lead and facilitate risk-management activities for products, processes, and changes.
Ensure risk assessments are technically sound, appropriately documented, and translated into effective controls.
Promote consistent use of risk-based decision-making across functions.
Ensure emerging risks identified through complaints, deviations, nonconformances, CAPAs and operational data are appropriately evaluated and incorporated into ongoing risk management.
Post market surveillance/vigilance activities
Nonconformances & Deviations
Provide Quality Engineering oversight for nonconformances and deviations, ensuring timely and technically robust investigations.
Ensure appropriate containment, product-impact assessment, root-cause analysis and disposition of affected material/product.
Partner with other functions to reduce recurring events and improve right-first-time performance.
Monitor trends in nonconformances and deviations and proactively initiate systemic improvement activities.
CAPA
Provide leadership and technical oversight for corrective and preventive actions.
Ensure investigations identify true root causes when possible and CAPA plans address identified systemic issues.
Ensure actions are appropriately risk-based, completed in a timely manner and supported by appropriate effectiveness verification.
Analyze CAPA trends and identify opportunities to prevent recurrence across products, processes or operations.
Complaint Support
Provide Quality Engineering support for complaint investigations, particularly where manufacturing, product, or process expertise is required.
Ensure complaint findings are appropriately connected to risk management, CAPA, nonconformance and continuous-improvement processes.
Identify and escalate significant or recurring product-quality trends.
Continuous Improvement
Lead/support Quality Engineering initiatives focused on improving product quality, process capability, reliability and operational performance.
Use quality data, statistical methods, and trend analyses to identify opportunities for proactive improvement.
Partner with Operations and Engineering to reduce defects, deviations, scrap/rework and other sources of poor quality.
Drive standardization and simplification of Quality Engineering processes and tools.
Champion Lean, problem-solving and continuous-improvement methodologies within the QE organization.
Quality & Compliance Responsibilities
Ensure Quality Engineering activities comply with applicable regulations, standards, procedures and company Quality System requirements.
Support internal, customer, and regulatory audits/inspections as the Quality Engineering subject-matter leader.
Ensure audit observations associated with Quality Engineering are investigated and addressed effectively.
Maintain inspection readiness within the function.
Escalate significant product-quality, compliance or business risks promptly to the Senior Manager, Quality.
Support Management Review and other Quality governance processes by providing relevant QE metrics, trends, risks and improvement plans.
Cross-Functional Leadership
Serve as the primary Quality Engineering partner to Operations, Engineering, and applicable product-development functions.
Influence cross-functional decisions to ensure appropriate consideration of product quality, customer impact, compliance and business risk.
Build effective working relationships across functions and resolve competing priorities using risk-based decision-making.
Represent Quality Engineering on project teams, operational reviews and other cross-functional forums.
Translate Quality requirements into practical solutions that enable the business while maintaining appropriate compliance and product-quality controls.
People Leadership
Recruit, onboard, coach, and retain a capable Quality Engineering organization.
Establish individual objectives aligned with Quality and business priorities.
Conduct performance and development discussions and provide timely feedback.
Develop technical depth and succession capability within the QE team.
Create an environment where Quality Engineers are expected to operate as proactive business partners and technical problem solvers, rather than primarily as reviewers or approvers.
Qualifications
Required
Bachelor’s degree in Engineering, Science, Quality or a related technical discipline. In lieu of this, comparable experience may be considered.
Typically 7+ years of progressive experience in Quality Engineering, Manufacturing Engineering, Product Engineering or a related technical function within a regulated environment.
Knowledge of and the ability to translate and apply the requirements of 21 CFR Part 820, ISO 13485, ISO 14971, IVDD, IVDR, and/or MDSAP.
Prior people-leadership, supervisory and/or demonstrated technical-leadership experience.
Demonstrated experience with nonconformance/deviation investigations, CAPA, root-cause analysis and risk management.
Experience supporting product/process changes, design activities, manufacturing operations and/or new product introduction.
Strong