Our client a global Medical Device manufacturing company are looking for a Senior Quality Manager to join an existing team reporting to the Head of QA. The company produce equipment, consumable medical devices and general laboratory equipment utlised in surgical settings and fem tech. This is a cross functional role where the chosen candidate will manage a team whilst working with internal and international teams/departments.
As the Senior Quality Manager, you will be responsible for overseeing the daily quality operations at the manufacturing site, ensuring regulatory compliance, implementation, and consistent performance of quality requirements.
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
- Ensure everyone in the organisation is aware of customer requirements.
- Promotion of awareness of applicable regulatory requirements related to QMS in the company
- Regulatory compliance regarding the EU MDR), and its verification in line with QMS
- Ensuring conformity of medical devices is checked, in accordance with the QMS before release
- Post-market surveillance obligations are complied with in accordance with MDR
- Ensuring the 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
- Coach, train and guide peers and team members - team management and stakeholder management is a key element of the position
- Establish where needed KPIs to track and measure performance of the QMS
- Review metrics and utilise statistical approach when providing feedback to the business
- Oversee document control procedures including preparation and review of quality policies
- Become an active part of the site leadership team
- Assist & mentor wider teams/departments on local and global manufacturing Medical device standards
Qualifications/Skills
- Ideally degree educated or similar practical expertise in Quality Management
- Quality Management within a licenced manufacturer, within Medical Devices
- Internal/External audit expertise, preferably a certified internal auditor (although not a deal breaker)
- People Management
- Ability to work on-site at least 4 days a week as this a manufacturer
To find out more about Real, please visit (url removed)
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy Registered office 8 Bishopsgate, London, EC2N 4BQ, United Kingdom Partnership Number OC(phone number removed) England and Wales
