QA/RA Officer

Join Genedrive as a QA/RA Officer and play a key role in delivering high-quality diagnostic solutions within the clinical and healthcare sector, supporting improved patient outcomes worldwide.

This is a fantastic opportunity for someone with at least 2 years’ Quality Assurance experience in a regulated environment, such as In Vitro Diagnostics (IVD), medical devices, or pharmaceuticals.

If you’re ready for the next step in your career and looking to make an impact in a dynamic and collaborative setting, we’d love to hear from you.

QA/RA Officer

Manchester, M13 9XX

* Full time, permanent position

* Office based

* £28,000 - £33,000 per year dependent on experience

Please Note: Applicants must be authorised to work in the UK

Genedrive is a leading diagnostics company operating within the IVD and healthcare sector.

The business develops innovative molecular diagnostic solutions that support improved patient outcomes worldwide. With a strong focus on quality, compliance and innovation,

Genedrive works closely with global partners, clinicians and laboratories to deliver reliable and impactful products.

About the Role:

As QA/RA Officer you will support the Quality Manager by assisting in maintaining an appropriate quality environment for the development and manufacture of products that meet the requirements of European and other Regulators as the company moves towards becoming a leading clinical diagnostics company.

Essential functions:

* Participate fully as a member of the Quality Team within and across the business.

* Provide Quality and Regulatory support to all departments within the business.

* Collaborate with internal and external stakeholders to ensure all our processes comply with the relevant standards and regulations.

* Collate and provide KPI’s, trend data and statistical analysis for Management Review and any other review boards where requested.

* Provide guidance on Risk Management activities.

* Provide guidance, support and maintain the Non-Conformance/Deviation system.

* Provide guidance and perform Root Cause Analysis into CAPA investigations.

* Assist in the review of Technical, Medical Device and Design History Files.

* Create, review, advise and provide guidance on interpretation of SOP’s.

* Review, advise and provide guidance on interpretation of Regulatory requirements

* Review Verification and Validation Data Reports and SOP’s and provide support during the Validation activities.

* Provide assistance with the maintenance of the electronic and hardcopy record archives.

* Perform internal Audits to a predefined schedule.

* Participate and support in external Inspections and Audits with clients, distributors and Notified Bodies.

* Perform other appropriate duties as assigned.

* Provide support and guidance for new product development projects.

Skills and qualifications:

* BSc in a Biological Science based degree.

* Proven experience (2 years or more) of working in Quality Assurance in the IVD or Medical Device Industry.

* Working knowledge of ISO 13485.

About you:

* Attention to detail.

* Organisational and prioritisation skills.

* Strong written and verbal communication skills.

* Problem solving.

* Ability to work alone and as part of a team.

If you’re looking to apply your skills in a role where quality, innovation and patient impact come together, Genedrive offers an excellent next step in your career.

How to apply for the role:

If you have the skills and experience required for this position, click “apply” today and check your inbox for an email providing more information on how to complete your application and provide any other supporting documents.

You must be authorised to work in the UK. No agencies please.

Other suitable skills and experience include Quality Assurance Officer, Quality Officer, QA Specialist, QA Associate, Regulatory Affairs Associate, Regulatory Affairs Officer, QA/RA Associate, Quality Systems Officer, Compliance Officer (Medical Devices/Pharma), Quality Engineer (Medical Devices)