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,…