Hobson Prior is seeking a Quality System Specialist for an exciting position based in Birmingham. The client is a world leader in specialised medical diagnostics and joining them will enable you to become part of a global community delivering new and innovative solutions to the market. This role will entail compiling and approving audit plans and reports, carry out audits and identify NCR.
- Make sure that all audit NCRs are fed through the NCR system as appropriate.
- Administration of NCRs and CAPAs on database including assessment of risk and escalation to corrective action.
- Support the investigation of causes, help with decisions to be taken and be able to set corrections/ corrective actions.
- Deliver direct assistance where required for large scale projects.
- Ensure training received is in-line with IRCA registration requirements, to gain a in-depth understanding of ISO13485/ ISO9001 and FDA Part 802 Quality Systems requirements.
- Ensure the current auditing programme is suitable and meets the requirements of ISO/FDA/Health Canada/ JPAL/ Anvisa and any other international requirements.
- Make sure that major and critical suppliers are audited to meet Regulatory and TBS requirements and ensure all supplier audits are carried out to plan as intended annually.
- Represent the company when needed at external audits.
- Computer literature with Microsoft Office and database experience.
- Ability to manage multiple projects.
- Good problem-solving skills with a meticulous eye to detail.
- Ability to communication with all levels of staff.
- Excellent communication skills both verbal and written.
- Biological or chemical based degree or equivalent.
- Qualified Lead Auditor.
- Training in FDA Quality System Requirements.
- In-depth understanding of ISO13485/IVD Directive/ FDA QSR.
- CAPA Management.
- Understanding of antibody/ antigen reactions.
- Previous experience with audit planning, execution and follow-up.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.