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Thermo Fisher

Quality Assurance Associate

East Grinstead, United Kingdom Full time

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

At our MBD East Grinstead facility, we are dedicated to maintaining the efficiency and applicability of Antibiotics in today’s ever-changing landscapes. The East Grinstead site is the only manufacturer of the Sensititre range of AST products; these vital products enable healthcare professionals to make an accurate diagnosis and to prescribe the right amount of the required antibiotic. Our Sensititre AST/ID products are also used globally in Veterinary and AST Research 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 profession al and fulfill your true potential. 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 with daily 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.

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.
  • Flexibility in meeting targets is essential.
  • Proficiency in the use of the MS Office suite.

Knowledge, Skills, Abilities:

  • Maintain accurate records. with attention to detail.
  • Ability to work independently and in a group setting with little direction or direct supervision.
  • Experience in audit involvement.
  • Priority oriented so 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. In a growing, expanding global organization, you will be encouraged to succeed. With revenues of $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make meaningful contributions to the world. The company has a broad range benefits scheme that you can tailor to your preference.

Each one of our 130,000 outstanding 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!