Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

As part of the Thermo Fisher Scientific team, you’ll 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 world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

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.

Key Responsibilities:

• Manage site Quality function in overall systems, products and processes to meet quality and relevant regulatory requirements as they pertain to CMD.
• Work with cross function team to ensure timely investigation of nonconformance / customer complaints and the implementation of effective corrective actions.
• Perform inspection of the returned materials and provide dispositions
• Oversee applicable inspection processes
• Support Customer, Regulatory and Corporate Audits.
• Ensure quality activities are in alignment with company goals, objectives and in compliance with QMS.
• Responsible for and acts as the Management Representative during any external audits where CMD requires representation
• Responsible for the inspection and product testing procedures to ensure consistent methods throughout the facility.
• Assure that issues potentially affecting product quality/compliance are brought to the attention of Senior Management
• This position is responsible for other duties as assigned.

Minimum Requirements/Qualifications:

• Advanced Degree plus 4 years of experience, or Bachelor's Degree plus 6 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
• A broad-based technical knowledge and skills in business areas such as Quality Engineering, Quality Assurance, Quality Systems, Supplier Quality, Regulatory and Quality Compliance is required.
• 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
• Experience with continuous improvement methodologies (Lean, Six Sigma)
• Ability to promote quality culture across all levels
• Project management experience preferred
• Strong written and oral communication skills, with the ability to collaborate and communicate effectively both externally and throughout the organization
• Skilled at analyzing data and summarizing results, as well as generating performance metrics to drive improvement
• Able to prioritize to meet objectives