Position: Quality Engineer
Business Title: Quality Engineer
Reports To: Quality Engineering Manager
Location: Cramlington, UK
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
The Quality Engineering role is primarily responsible for the effective investigation of customer complaints through utilization of root cause tools in order to determine the root cause of the failure and establish robust corrective and preventative actions in order to prevent recurrence and drive down customer complaints on site. Quality Engineers will effectively engage with on-site departments, suppliers and other SUT sites to drive investigations to determine the root cause. Customer engagement will also form a key part of the Quality Engineers role who will routinely communicate complaint responses, provide feedback and participate in customer conference calls.
Develop relationships with customers and the commercial team
Lead investigations for customer complaints and internal process failures
Drive the implementation of effective and appropriate CAPAs
Work closely with the Operations group to provide technical support for products and processes
Conduct internal audits and risk mitigation activities
Analyse data to drive process improvements
Provide assistance with routine validations
Provide support for onsite Customer audits
Complete QA responsibilities in QMS systems
Degree in a Scientific or Engineering based subject or significant experience within the Pharmaceutical/Biotech industry
Experience working in a Quality role
Internal auditing experience
Working knowledge of GMP and working to ISO13485 standards
Attention to detail
Able to work to strict deadlines under pressure
Exceptional report writing skills
Excellent IT skills in MS Office
Self-assertive and able to drive new initiatives
Good communication skills
At Thermo Fisher Scientific, each one of our 80,000 extraordinary minds have a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.