:
• Ensure that general day to day activities such as approval of manufacturing documentation including technical reports, review/approval of non-conformances, deviations, reviewer/approver for SOP’s, briefs, software, specifications and forms
• Ensure compliance and assist in the audits (pre audit and post audit follow up) to external (regulatory) requirements, including Quality Management Systems (ISO 13485:2016, MDSAP) and the In Vitro Diagnostics Regulations.
• Ensure corrective actions are implemented for issues arising from the audits.
• Responsible for reviewing and approving SOPs in line with change process.
• Co-ordinate investigation of customer complaints and general quality advice to the business.
• Undertake QA responsibilities regarding supplier control, review and performance.
• To act as coordinator and/or QA Representative on Corrective Action investigations.
• Perform internal audits to ensure compliance to external regulatory requirements.
• Assist in metric data for the Quality department.
• Assist in training for Quality functions and relevant documentation in up-to-date
• Any other duties/projects as are reasonable and within the skills and ability of the post-holder.
Minimum Requirements/Qualifications:
• Degree in microbiology/degree in a related field
• Confirmed experience in a QMS role preferably within MDR/IVDR
• High attention to detail
• Ability to communicate openly
• Ability to work flexibly to ensure targets are met
• Competency in the use of the MS Office suite
Knowledge, Skills, Abilities:
• High attention to detail and able to maintain accurate records. Ability to work independently and in a group setting with little direction or direct supervision.
• Experience in audit involvement.
• Work flexibly to ensure deadlines are met
• Experience with writing concise/accurate reports
When you’re part of Thermo Fisher Scientific, you’ll do challenging work with a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world. The company has a broad range benefits scheme that you can tailor to your preference. At Thermo Fisher Scientific, each one of our extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.