JOB DESCRIPTION

Company Information
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory efficiency. Our four premier brands – Life Technologies, Thermo Scientific, Fisher Scientific and Unity Lab Services – offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com.

POSITION SUMMARY

Lead and enhance quality assurance practices in Thermo Fisher Scientific East Grinstead site. Coordinate and manage a team of quality professionals and serve as the main contact for all Quality matters affecting daily operations. Facilitate SOP management, training efficiency, investigations, change controls, in-process controls, and validation, recommending process improvements for better performance and compliance. Promote quality subject areas and use detailed problem-solving to address quality issues.

MINIMUM REQUIREMENTS/QUALIFICATIONS

• Bachelor’s degree in a scientific subject or related field.
• Proven experience in a regulated industry, ideally in quality assurance within medical device or pharmaceutical manufacturing.
• Experience managing and developing a team in a quality environment.
• Strong background in process control and statistical techniques.
• Knowledge of medical device regulations, cGMP, EU Regulation, or ISO 13485.
• Strong interpersonal skills, both oral and written.
• Self-starter with the ability to produce results from general concepts and direction.
• Ability to prioritise multiple tasks in a global, multi-site organisation.
• Effective cross-functional team collaboration.
• Proficiency in quality tools such as FMEA, SPC, DOE, and Six Sigma/PPI.
• Strong digital literacy, including SAP, Microsoft Word, Excel, and PowerPoint.
• Expertise in qualification/validation (process, sterilisation, cleaning, software).

• Lead and coordinate the site’s Quality team
• Provide Quality leadership for investigations, deviations, change controls, validation, SOPs, and in-process controls.
• Champion collaborative relationships between Operations and Quality to improve customer experience.
• Assist other functions in troubleshooting and resolving process and quality issues.
• Work with Operations, R&D, Purchasing, and Engineering to improve quality and reduce costs.
• Focus on efficiency and compliance improvements in quality management.
• Partner with Operations to establish controls and inspection points for nonconforming materials, parts, assemblies, and products.
• Act as the Quality Representative for all quality-related corrective/preventive actions.
• Ensure compliance with division policies, national and international codes, and safety requirements.
• Analyse trends, conduct root cause analysis, and implement corrective actions for processes and products.