Quality Engineering Manager: NPI, CAPA & Compliance Leader

RXinsider LTD.; Fremont (CA); Hybrid; USD 113,000 - 150,000; Full time

Benefits offered by this job

Total Rewards package

401(k) retirement plan

Paid time off & holidays

Parental leave

Job summary

Thermo Fisher Scientific in California seeks a Quality Engineering Manager to lead the QE team, guiding risk-based decisions across product lifecycles. You will drive CAPA, NC, deviations investigations and ensure NPI quality deliverables are met.

Reporting to the Senior Manager, Quality, you will partner with Engineering, Operations, R&D and other functions to ensure compliance with 21 CFR Part 820, ISO 13485, ISO 14971, IVDD/IVDR, and MDSAP, while developing a proactive quality culture.

Qualifications

• Bachelor’s degree in Engineering, Science, Quality or related field; comparable experience 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 written and verbal communication skills.

Responsibilities

• Lead and coach Quality Engineering team, establishing clear responsibilities, priorities, and performance expectations.
• Ensure compliance and risk-based decision-making across functions.
• Support design reviews, qualification/validation activities, change implementation and manufacturing readiness.
• Ensure Quality deliverables for NPI projects are defined, appropriately resourced and completed.
• Drive CAPA, NC, deviations investigations and effectiveness verification.
• Promote a culture of accountability, collaboration, continuous improvement and quality ownership.

Skills

Quality Leadership

Root Cause Analysis

Risk Management

Cross-functional Collaboration

Data Analysis

Education

Bachelor's degree in Engineering, Science, Quality or related

Tools

MS Office

Microsoft Teams

Smartsheet

Adobe Acrobat

Job description

Thermo Fisher Scientific in California seeks a Quality Engineering Manager to lead the QE team, guiding risk-based decisions across product lifecycles. You will drive CAPA, NC, deviations investigations and ensure NPI quality deliverables are met.

Reporting to the Senior Manager, Quality, you will partner with Engineering, Operations, R&D and other functions to ensure compliance with 21 CFR Part 820, ISO 13485, ISO 14971, IVDD/IVDR, and MDSAP, while developing a proactive quality culture.