Quality Manager, Regulatory & Continuous Improvement

ThermoFisher Scientific; Bothell (WA); On-site; USD 105,000 - 145,000; Full time

Benefits offered by this job

Total Rewards package

Medical & dental plans

Vision plan

Paid time off & holidays

Parental leave

Job summary

Thermo Fisher Scientific seeks a Quality Manager to lead quality initiatives across our global operations, ensuring compliance with ISO and FDA standards. You will guide continuous improvement, mentor teams, and collaborate with cross-functional partners to protect patient safety and deliver high-quality products and services.

The role emphasizes leadership, regulatory expertise, and the ability to implement robust quality systems, with a focus on Lean/Six Sigma methodologies and a culture of

Qualifications

• Advanced degree with 6+ years in pharma/med device quality
• Bachelor's degree with 8+ years in quality in regulated industry
• Lead Auditor ISO 9001 preferred
• 3–5 years of leadership/management experience
• Comprehensive knowledge of ISO 9001, ISO 13485, FDA QSR/cGMP
• CAPA, risk analysis, FMEA, root cause analysis
• Experience leading audits and regulatory inspections
• Mentor quality teams and implement quality systems
• Cross-functional collaboration and stakeholder management
• Analytical and problem-solving capabilities
• Clear written and verbal communication
• TrackWise and Document Control Systems
• Lean, Six Sigma experience

Responsibilities

• Guide quality initiatives and continuous improvement
• Ensure adherence to regulatory requirements
• Maintain a culture of compliance and operational excellence
• Collaborate across functions to drive quality outcomes
• Support protecting patient safety and enabling research

Skills

Quality management

Regulatory knowledge

CAPA

Risk analysis

FMEA

Root cause analysis

Audits

Leadership

Cross-functional collaboration

Project management

Communication

Education

Advanced degree (any field)

Bachelor's degree in related field

Tools

TrackWise

Document Control Systems

Job description

Thermo Fisher Scientific seeks a Quality Manager to lead quality initiatives across our global operations, ensuring compliance with ISO and FDA standards. You will guide continuous improvement, mentor teams, and collaborate with cross-functional partners to protect patient safety and deliver high-quality products and services.

The role emphasizes leadership, regulatory expertise, and the ability to implement robust quality systems, with a focus on Lean/Six Sigma methodologies and a culture of