Description
My client is a small Medical device business based in South Wales that is now looking for a Quality & Regulatory Manager to join their innovative team.- Leadership and management of QA, QC and post-market RA groups directly or indirectly through subordinate supervisory staff.
- Responsible for ensuring all post-market quality system and regulatory affairs requirements are met by the department.
- Responsible for collaborating and supporting all the premarket regulatory affairs and design assurance team to ensure all initiatives are completed in a timely and compliant manner.
- Responsible for ensuring all quality control requirements are met by the QC group.
- Maintenance of the quality function with compliance to ISO 9001, 13485, FDA, CMDR, and corporate standards.
- Identify and implement/re-design process improvements in the Quality operation.
- Identify issues that arise in Quality in relation to products and be able to investigate and resolve problems as they arise.
- Ensure all Quality staff are trained to be competent in all areas as detailed on the Quality Skills assessment and training needs identified during staff appraisals.
- Writing monthly reports and also as requested
Essential requirements.
- Working knowledge within Medical Devices experience.
- Management experience coupled with team leadership
- Relevant experience with increasing levels of responsibility managing medical device quality systems.
- Familiar with the activities to be carried out within the appropriate procedures for Quality System to ISO 9001, 13485, FDA and CMDR standards
- Experience of internal and external audits
- High attention to detail.
- Able to deal with issues confidentially.
If you believe you have the correct experience then please send me your CV and I will be in touch shortly.