Quality Control Manager

Overview

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc. allowed, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Warehouse. As a Quality Manager at Thermo Fisher Scientific, you will contribute to excellence across our quality management systems while enabling our mission to make the world healthier, cleaner and safer.

You will guide quality initiatives, support continuous improvement, and cultivate a culture of compliance and operational excellence. Working collaboratively across functions, you will ensure adherence to regulatory requirements while maintaining the highest quality standards for our products and services. This role offers the opportunity to make a meaningful impact by protecting patient safety, supporting innovative research, and enabling critical scientific discoveries.

• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in quality experience in pharmaceutical, medical device or regulated industry
• Preferred Fields of Study:
  Chemistry, Biology, Engineering, Pharmacy, or related scientific/technical field
• Lead Auditor certification in ISO 13485/9001 preferred
• 3-5 years of leadership/management experience
• Comprehensive knowledge of quality management systems and regulations (ISO 9001, ISO 13485, FDA QSR/cGMP)
• Strong understanding of quality tools and methodologies (CAPA, risk analysis, FMEA, root cause analysis)
• Experience leading internal/external audits and regulatory inspections
• Demonstrated ability to develop and mentor quality teams
• Successful experience implementing and improving quality systems
• Skill in cross-functional collaboration and stakeholder management
• Strong analytical and problem-solving capabilities
• Clear written and verbal communication skills
• Proficiency with quality management software (Track Wise, Document Control Systems)
• Experience with continuous improvement methodologies (Lean, Six Sigma)
• Ability to promote quality culture across all levels
• Focus on customer needs and ability to manage customer/supplier relationships
• Project management experience preferred
• Up to 20% travel may be required