Engineer I, QA - #144514

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

Location/Division Specific Information

Warrington Operations, Cheshire UK

A day in the Life

As part of the Quality Team, you will assure the quality of current and future products and satisfy the exceptionally high expectations of our customers. Successfully implement solutions for diverse challenges and strive for continual improvement of Quality Management System processes.

Keys to Success

• Offer mentorship in all areas of the Quality Management System, including corrective & preventive actions, product complaints, post-market surveillance, change control, nonconformance, Out of Specification processes, risk management, and internal and external audit support.
• Review batch records during QA tier review, ensuring GDP and critical manufacturing processes are strictly adhered to.
• Actively participate in New Product Development core teams, reviewing design history documents to ensure compliance and document deliverables meet design requirements.
• Mentor and provide guidance in manufacturing areas, assist with issue management, and ensure compliance and quality assurance align with customer needs.
  
  

Education

• Degree in a scientific field or equivalent experience in a relevant subject area
  
  

Experience

• Demonstrated ability in a regulated industry –Pharma or Biotech as examples
• Experience of operating within a quality management system such as ISO13485
  
  

Knowledge, Skills, Abilities

• Knowledge of 13485 and internal auditing
• Knowledge of risk assessment in line with ISO14971
• Experience with Quality Improvement Tools (5 Why/Pareto analysis/Run Charts)
• Experience of CAPA processes & problem solving within Process/Product Improvement multi-functional teams
• Ability to mentor and influence others is crucial
• Travel requirements: some travel may be required – 10% max