Quality Engineering Manager - Lead NPI & Compliance

ThermoFisher Scientific; Fremont (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Thermo Fisher Scientific in Fremont, CA seeks a Quality Engineering Manager to lead the QE team and drive quality throughout product and process lifecycles. You will partner with Engineering, Operations, R&D and other functions to ensure compliance with 21 CFR Part 820, ISO 13485, and related standards.

You will oversee NPI activities, CAPA programs, nonconformances, deviations, and risk management, guiding continuous improvement and a proactive quality culture across the organization.

Qualifications

• Bachelor’s degree in Engineering, Science, Quality or a related field.
• 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 apply 21 CFR Part 820, ISO 13485, ISO 14971, IVDD, IVDR, and/or MDSAP.
• Prior people-leadership, supervisory and/or demonstrated technical-leadership experience.
• 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 written and verbal communication skills.
• Ability to work without close supervision and produce quality work.

Responsibilities

• Lead and develop the Quality Engineering team with clear responsibilities and performance expectations.
• Manage day-to-day QE resources based on product, project, compliance and risk.
• Drive quality culture with documentation and standardized QE practices.
• Lead CAPA, NCs, deviations and complaints investigations and resolutions.
• Promote risk-based decision-making across functions.
• Support audits and maintain inspection readiness for QE activities.
• Drive NPI quality deliverables and assess product/process risks in development and implementation.

Skills

Analytical thinking

Problem solving

Written & verbal communication

Proactive / self-starter

Education

Bachelor’s degree in Engineering, Science, Quality or related field

Tools

MS Office

Smartsheet

Visio

Adobe Acrobat

Job description

Thermo Fisher Scientific in Fremont, CA seeks a Quality Engineering Manager to lead the QE team and drive quality throughout product and process lifecycles. You will partner with Engineering, Operations, R&D and other functions to ensure compliance with 21 CFR Part 820, ISO 13485, and related standards.

You will oversee NPI activities, CAPA programs, nonconformances, deviations, and risk management, guiding continuous improvement and a proactive quality culture across the organization.