Supervisor, QA (Quality Systems Engineer)

Work Schedule

• Environmental Conditions
• Job Description
• 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.
• DESCRIPTION
• How you will make an impact:
• Manage the ISO 9001 internal audit programme, including auditor qualification and competency maintenance, and conduct audits in line with the approved schedule
• Liaise with customers regarding regulatory, compliance and technical issues
• Coordinate and lead external audit activites with customers
• Ensure technical files are up to date and in full compliance with IVDR (EU) 2017/746
• Liaise with Certification & Notified Bodies regarding ISO certification issues and CE marking of product
• Liaise with the MHRA and other Competent Authorities regarding regulatory compliance to IVDR
• Manage the customer complaints process, ensuring effective root cause analysis has been carried out and that corrective action plans are produced, are effective and completed within agreed timescales
• Produce customer complaint reports and ensure customer complaint response times comply with company targets