Based from their R & D centre in Inverness, ODx Innovations is a well-resourced early stage company developing a highly innovative, rapid and cost-effective point of care (POC) testing solution for Antibiotic sensitivity testing. Entering the next stage of their exciting and ambitious growth, ODx are seeking an experienced Senior Quality Engineer to support the organisation in developing cost-effective, accurate and speedy point-of-care solutions to address the growing problem of bacterial resistance to antibiotics. The role
You will support the Quality Manager in designing, developing and managing Quality systems , processes and procedures to meet product development requirements and ensure compliance with all company, industry and regulatory requirements.
A highly experienced Senior Quality Engineer, you will have a broad and varied remit including;
- Deputising for the Quality Manager and assisting in daily operational activities
- Ensure ODx product lifecycle activities meet global market regulatory requirements
- Assist and lead, as necessary, internal and external audits of ODx facility
- Participate in management reviews of the QMS and associated authoring and management of quality documentation
- Support QMS audits for the organisational business Plan and assist in delivering the QMS infrastructure required to achieve ISO13485 certification
- Develop and rollout quality strategy and processes to ensure continuous process improvement and dissemination of good practice
- Lead the organization's quality risk management and mitigation strategy
Ideally degree qualified or possessing relevant in-depth industry experience, you will be able to demonstrate proven experience in a Senior or Lead Quality Engineering role. You will have led and supported all elements of Quality Management systems and operations within a highly regulated environment, ideally within the Life Sciences or associated sectors. You will have an in-depth working knowledge of all areas of the Quality Engineering function including process, supplier and QMS development.
Previous experience in implementing and maintaining a Quality Management System compliant to ISO13485 and FDA 21CFR Part 820 within a Medical Device Manufacturing environment preferred. A Six Sigma or associated qualification would be highly desirable.
Eden Scott are working as recruitment partner with ODx and any direct or referral applications will be forwarded to them for inclusion in the recruitment campaign - any candidate submissions from alternative sources will not be considered.
For an informal discussion or for further details on this outstanding opportunity, please call Ian Grant on 0141 410 1005 or e-mail your current CV to email@example.com.