QA Associate - #147116

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

When you’re part of Thermo Fisher Scientific, you’ll do exciting 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.

Position Summary: Our MBD East Grinstead facility is at the forefront of our quest to keep Antibiotics effective and relevant for today’s demanding environments. The East Grinstead site is the only manufacturer of the Sensititre range of AST products, critical in the fight against primary infections and Covid 19 secondary infections. These vital products enable healthcare professionals to make an accurate diagnosis and to prescribe the right amount of the required antibiotic.

Working with our East Grinstead Sensititre products, our customers save lives every day and we help them to make the world healthier, cleaner and safer. What we do makes a difference!

Our Sensititre AST/ID products are used globally to determine which antibiotics a particular bacterium is sensitive or resistant to and help to ensure patients are given the most appropriate treatment. Sensititre products are used in Clinical, Pharmaceutical and Veterinary settings.

Playing a key role in our Site Mission is the Quality Assurance team, who ensure that all medical devices manufactured on site are compliant to the Quality Management System as per ISO 13485:2016. This team is both dynamic and diverse, with plenty of scope for development and progression within the structure.

This is a huge opportunity to learn from the best, develop as a quality professional and fulfill your true potential. You will be part of a team who are a key interface across the various areas on site. Working within this team you will ensure product release and documentation for the QMS is maintained as part of document control and control of records. The position requires a proficient communication and IT skills to support the site on the day to day administration of key quality tasks such as batch release and new product approvals.

Responsibilities:

• 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.