Senior Quality Assurance Manager
3 weeks ago
Job Title: Senior Quality Assurance Manager
Location: Not Specified
We are seeking a Senior Quality Assurance Manager to join our team at Real. The successful candidate will be responsible for overseeing the daily quality operations at the manufacturing site, ensuring regulatory compliance, implementation, and consistent performance of quality requirements.
About Us:
Real is a global Medical Device manufacturing company that produces equipment, consumable medical devices, and general laboratory equipment used in surgical settings and fem tech.
About the Role:
The Senior Quality Manager will ensure the quality management system is implemented and maintained in accordance with ISO 13485, and will act as management representative for the QMS.
Responsibilities:
- Ensure monitoring and correction of the quality management system according to ISO 13485
- Act as management representative for the QMS
- Ensure QMS processes are established, implemented, and maintained
- Report to senior management on the QMS performance and where improvements are needed
- Promote awareness of applicable regulatory requirements related to QMS in the company
- Ensure regulatory compliance regarding the EU MDR and its verification in line with QMS
- Ensure conformity of medical devices is checked, in accordance with the QMS before release
- Post-market surveillance obligations are complied with in accordance with MDR
- Ensure reporting obligations referred to in Articles 87 to 91 of the MDR are fulfilled
- Ensure updating and maintenance of the Quality manual
- Control and management of all CAPA activities and execution of internal audits
- Candidate must have strong people management skills and be able to work on-site at least 4 days a week
- Strong audit experience preferred but not required
Qualifications/Skills:
Ideal candidate will have degree educated or similar practical expertise in Quality Management within a licensed manufacturer, preferably in Medical Devices.
Salary:$100,000 - $150,000 per year
About Real:
To find out more about Real, please visit our website.
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