Quality Manager - GMP/ISO Leader, Continuous Improvement

Regulatory Jobs; Bothell (WA); On-site; USD 105,000 - 145,000; Full time

Benefits offered by this job

Medical plans

Dental plan

Vision plan

PTO 120 hours

Holidays

Parental leave

401(k) plan

ESPP

Job summary

Thermo Fisher Scientific seeks a Quality Manager to drive quality initiatives and maintain compliance across our quality systems. You will guide continuous improvement, mentor teams, and support regulatory inspections while protecting patient safety and enabling scientific innovation.

Collaborating across functions, you will ensure adherence to ISO and FDA requirements, promote a culture of quality, and lead efforts to optimize quality tools and processes.

Qualifications

• Advanced degree with substantial quality experience.
• Experience in pharmaceutical, medical device, or regulated industry.
• Lead auditor certification in ISO 9001 preferred.
• Strong regulatory knowledge (ISO 9001/13485, FDA QSR/cGMP).
• Experience leading audits and regulatory inspections.
• Mentor and develop quality teams.

Responsibilities

• Lead quality initiatives and continuous improvement across functions.
• Ensure compliance with regulatory requirements and quality standards.
• Guide teams in CAPA, risk analysis, and root cause analysis.
• Collaborate to maintain high product and service quality.

Skills

Quality management

Regulatory compliance

Auditing

Leadership

Cross-functional leadership

Problem solving

Data analysis

Project management

Communication skills

Lean Six Sigma

Education

Advanced degree

Bachelor's degree

Tools

TrackWise

Document control systems

Job description

Thermo Fisher Scientific seeks a Quality Manager to drive quality initiatives and maintain compliance across our quality systems. You will guide continuous improvement, mentor teams, and support regulatory inspections while protecting patient safety and enabling scientific innovation.

Collaborating across functions, you will ensure adherence to ISO and FDA requirements, promote a culture of quality, and lead efforts to optimize quality tools and processes.