Quality Control Manager

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

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

Job Description

As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
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.

REQUIREMENTS:
Advanced Degree plus 6 years of experience or Bachelors 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 (TrackWise 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