Quality Manager

Quality Manager role at Thermo Fisher Scientific focused on advancing quality management systems and regulatory compliance in a pharmaceutical or medical device manufacturing setting. The position involves guiding quality initiatives, supporting continuous improvement, and fostering a culture of operational excellence across cross-functional teams.

Responsibilities

• Guide quality initiatives and continuous improvement efforts across the organization
• Ensure compliance with regulatory requirements and maintain highest quality standards
• Lead internal and external audits and support regulatory inspection processes
• Develop, mentor, and build high-performing quality teams
• Implement and improve quality management systems while promoting quality culture

Requirements

• Advanced degree plus 6 years, or bachelor's degree plus 8 years in quality within pharmaceutical, medical device, or regulated industry
• 3-5 years of leadership and management experience
• Comprehensive knowledge of ISO 9001, ISO 13485, FDA QSR/cGMP regulations
• Expertise with quality tools including CAPA, risk analysis, FMEA, and root cause analysis
• Lead Auditor certification in ISO 9001 preferred
• Experience with quality management software such as TrackWise or document control systems
• Familiarity with continuous improvement methodologies like Lean or Six Sigma

Compensation: $105,000–$145,000 base