QAagency is delighted to be working with a global leader in in-vitro diagnostics, supporting their continued growth at their UK site in Dartford, Kent. As part of their focus on quality and regulatory excellence, they are now seeking a Quality Assurance Specialist to manage key post-market and quality systems functions in a highly regulated environment.
As a Quality Assurance Specialist, you will support product quality and regulatory compliance by managing customer complaints, risk evaluations, and post-market surveillance activities. You’ll ensure risk management processes align with ISO 14971, support labelling and packaging control, and contribute to vigilance reporting and field action coordination. This is a full-time, on-site role (37.5 hours/week) with no hybrid working.
- Manage customer complaints, post-market surveillance, and field safety actions.
- Conduct risk assessments and maintain risk management documentation.
- Support labelling and packaging compliance for IVD products.
- Liaise with regulatory bodies regarding reportable events and batch verifications.
Key Requirements
- 3–5 years’ experience in quality, development, testing, or manufacturing.
- Familiar with ISO 13485, ISO 14971, and IVDD/IVDR standards.
- Strong communication and interpersonal skills across departments.
- Detail-focused, proactive, and able to manage multiple priorities.
This position offers a salary of £35,000 and a competitive benefits package including:
- Private medical insurance for the individual (with the option to add family)
- Pension contributions up to 12% (when the employee contributes 6%)
- Group life assurance and income protection
- 25 days annual leave plus bank holidays, with the option to buy or carry over up to 5 days
- Free on-site parking and online retail discounts
- Convenient location, 10-minute walk from Dartford train station