Company Background
This company is a global provider of life science reagents, tools, and consumables, with a strong focus on the medical devices and diagnostics sectors.
Through strategic acquisitions, they have built a robust portfolio of in-vitro diagnostic (IVD) medical devices, diagnostic kits, and reagents that serve a wide range of industries, including healthcare, pharmaceuticals, and veterinary medicine.
Their UK operations have been significantly strengthened by the acquisition of companies specializing in medical diagnostic kits and ELISA (enzyme immunoassay) products, which are used in clinical testing for infectious diseases and other health conditions
Issues and needs
Due to the rapid growth of the company, it was looking to build out and establish a centre of excellence to base their Quality & Regulatory divisions out of. Also, following multiple sites being acquired there was many difference Quality systems in place being managed by different people – they needed it all to come together!
First of all they needed a Quality Engineer:
To support manufacturing and quality operations, focusing on product quality, new product introductions, and process improvements. Reporting to the RAQA Director, the role involved QA review, validation planning, process control, and cross-functional collaboration to ensure compliance with regulatory standards and drive continuous improvement across the product lifecycle.
Result
Job qualified on 1st February 2024, the hired candidate was sent on 2nd February 2024 and offer presented and accepted on the 26th February 2024 and started 11th March 2024.
Next also needed a Regulatory Lifecycle Specialist:
To ensure ongoing compliance with UK and Ireland regulations for medical devices. Reporting to the Quality Assurance and Regulatory Manager, the role involved managing technical documentation, compiling regulatory submissions, and overseeing license renewals. The specialist was responsible for ensuring compliance with EU MDR/IVDR standards, responding to regulatory queries, and maintaining PMS data.
Result
Job qualified on 1st February 2024, the hired candidate was sent on 13th February 2024 and offer presented and accepted on the 26th February 2024 and started on 18th March 2024.
Next they needed an RA/QA Manager:
To oversee the regulatory compliance and quality assurance function. This role was responsible for establishing and maintaining a unified QMS across the campus, ensuring compliance with relevant device standards and regulations. The RCQA Manager worked closely with site leadership to identify and mitigate compliance risks, manage audits, and handle customer service inquiries. Key responsibilities included quality planning, change management, audit hosting, and staff development, all while ensuring the site’s continued adherence to company policies and procedures.
Result
Job qualified on 23rd March 2024, the hired candidate was sent on 4th April 2024 and offer presented and accepted on the 25th April 2024 and started on 6th June 2024.
Next they needed a Quality Coordinator:
To ensure compliance and maintain the QMS at their UK headquarters. The role involved managing both electronic and paper-based quality processes, including document control, non-conformances, corrective actions, and training programs. Key responsibilities included supporting the integration of acquisitions into the QMS, facilitating audits, maintaining supplier quality assurance, and producing metrics to track system health. The position required collaboration across teams to drive continuous improvement and ensure compliance with ISO 9001/13485 standards. Reporting to the newly appointed RA/QA Manager.
Result
Job qualified 15th July 2024, the hired candidate was sent on 16th July 2024 and offer presented and accepted on the 29th July 2024 and started on 20th August 2024.
Overview
Stirling Q&R managed to secure 4 NEW key hires for the company within a short time period with the longest job qualification to offer timescale being 55 days and the shortest being 14 days!
Stirling Q&R was made the exclusive partner in this recruitment effort which made the process so straightforward and quick, we were able to prove just how quick an accurate we work, especially reducing time to hire!
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