Description
Diagnostics Quality Manager - £45,,000 plus benefits - North East, EnglandAn international diagnostics company are looking for an experienced Quality Assurance Manager to support their international growth.
The Job:
- Experience of managing a team, this role will have 2 direct and 2 indirect reports
- Implementing, reviewing, updating, authorising & maintaining the Quality Management System (QMS).
- Reporting to Management on the performance of the Quality Management System and any need for improvement.
- Ensure the company and the company's equipment, employees, products and processes are compliant with appropriate regulations
- Plan, budget for, and maintain adequate resources necessary to efficiently execute QA operations
- Provide release/certification for final products together with QA support. Ensuring that GMP and company procedures (SOPs) are adhered to
- Interface with R&D and Operations departments to ensure the efficient and compliant transfer of new products.
- Conduct/Co-ordinate internal and Supplier Quality audits.
- Hosting third party and regulatory body audits.
- Ensuring suppliers are suitably assessed for criticality, and actions are taken to minimise the risk to manufacturing process posed by suppliers
- Develop training to build quality awareness. Developing cross functional approach to quality awareness and improvement.
Skills Required:
- Thorough working knowledge of the EU IVDD, US 21 CFR 820, ISO 13485.
- Knowledge of validation requirements and validation strategy as applied to medical device products, processes and equipment.
- Particular knowledge of regulatory requirements for product registration in the EU and US; other territories would be beneficial.
- Ability to build/improve Quality Management Systems that are appropriate for purpose.
- Have a good understanding of IVD products.
- Knowledge of the medical device problem reporting requirements and systems in the EU, US and Canada
Experience Required:
- Minimum of 5 years experience in quality functions related to medical devices (preferably IVD)
- Minimum of 3 years experience in a management position managing all aspects Medical Device Quality; with a track record of successful results.
- Proven experience in hosting third party and regulatory body audits/inspections
- Proficient in the improvement or design and implementation of quality systems including change management, CAPA, complaint handling and vigilance reporting
- Proven track record of continuous quality improvement within Quality Assurance areas.
- Experience of lean manufacturing, six sigma methodologies
This role is looking to pay up to £55,000 and is an excellent position for someone looking to embrace an exciting new opportunity within a growing organisation. If you are interested in this position, please contact Jonny Montgomery on for further details.
To find out more about Real please visit www.realstaffing.com