ODx Ltd is a UK based R & D Partner collaborating with leading global providers of sophisticated products for life science research and clinical diagnostics markets. Developing technologies to transform the performance of antibiotic sensitivity testing laboratory and point-of-care products,
With a mission to bring cost-effective, accurate and speedy technology solutions to address the growing problem of bacterial resistance to antibiotics, ODx are developing technologies which will be relevant in several medical environments, will dramatically increase the speed of results for patients and will enable faster and more accurate prescription of the most appropriate drugs.
An experienced Quality Auditor, you will have a challenging, dynamic and fast-paced role within a talented Quality team, working closely with the Quality Manager / Responsible Person to ensure QA team to ensure compliance with all company and client procedure, industry regulations and legislation.
You will have a broad and varied role, your duties and responsibilities including
- Preparation, undertaking and management of all internal and external regulatory ISO audits across all areas of operational activities from product design and development through all stages to scale-up and manufacture
- Assisting in the day-to-day management of the quality system to ensure compliance against ISO 13485 requirements.
- Providing Quality Assurance (QA) support to initiate, engage and escalate critical and major compliance issues through QMS processes, including deviations, CAPAs and change control.
- Managing and monitoring the KPIs for the business, identifying trend areas and communicate to key stakeholders to drive improvement.
- Co-ordinating audits in preparing and participate in hosting both internal and external audits with customers and regulatory authorities.
- Supporting the maintenance of the annual supplier evaluation schedule to ensure compliance to process and QMS.
- Supporting project implementations ensuring compliance to QMS activities including validation.
- Liaising with all relevant stakeholders to ensure they are up to date and trained on QA systems, processes and changes and liaising with suppliers to ensure compliance
- Ensuring that queries/issues are investigated and resolved including improvements, corrective and preventative actions in a timely fashion to minimise risks and costs.
- Acting as a quality assurance point of contact for the internal departments and customers to ensure compliance.
- Attending internal and external meetings representing ODx quality assurance.
- Training and providing assistance to business functions on quality procedures, protocols, and documentation.
Ideally degree qualified, an experienced Quality Auditor you will have a wealth of experience undertaking and managing ISO auditing across all areas of operational activities and managed ISO audits with relevant regulatory authorities. In addition, you will be well versed in managing all elements of Quality Audit and Quality Assurance within a highly regulated environment, direct experience within the medical device/ life sciences sector preferred. You will have an in-depth working knowledge of reviewing SOPs, working instructions and quality agreements for suppliers, experience of being involved in regulatory audits and undertaken regular Root Cause Analysis, CAPA and Non -Conformance reporting and management and control of associated corrective actions.
You will be a strong influencer, a good communicator and be able to engage and work with a variety of internal and external stakeholder groups. Experience working within IOS 13485 or 9001 environments is essential. You will ideally reside in a travel to work location although the role will be a combination of office and home based and full consideration will be given to candidates out with but willing to travel regularly to site and as required to meet audit schedules.
In conjunction with affording the opportunity to support product development within a highly innovative organisation you will be afforded a genuine opportunity to play a key role within a dynamic team supporting the growth and development of exciting technologies and cutting-edge healthcare technology.
Eden Scott is working as recruitment partner with ODx, for an informal discussion or for further -details on this outstanding opportunity, please call Ian Grant on 07584 676 007 or email email@example.com.