Senior Quality Manager

Our client, a global Medical Device manufacturing company, is looking for a Senior Quality Manager to join an existing team reporting to the Head of QA. The company produces equipment, consumable medical devices, and general laboratory equipment utilized in surgical settings and fem tech. This is a cross-functional role where the chosen candidate will manage a team while 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:

1. Ensure monitoring and correction of the quality management system according to ISO 13485.
2. Act as management representative for the QMS.
3. Ensure QMS processes are established, implemented, and maintained.
4. Report to senior management on the QMS performance and where improvements are needed.
5. Ensure everyone in the organization is aware of customer requirements.
6. Promote awareness of applicable regulatory requirements related to QMS in the company.
7. Ensure regulatory compliance regarding the EU MDR and its verification in line with QMS.
8. Ensure conformity of medical devices is checked in accordance with the QMS before release.
9. Ensure post-market surveillance obligations are complied with in accordance with MDR.
10. Ensure reporting obligations referred to in Articles 87 to 91 of the MDR are fulfilled.
11. Ensure updating and maintenance of the Quality manual.
12. Control and manage all CAPA activities and execute internal audits.
13. Coach, train, and guide peers and team members; team management and stakeholder management are key elements of the position.
14. Establish KPIs to track and measure the performance of the QMS where needed.
15. Review metrics and utilize a statistical approach when providing feedback to the business.
16. Oversee document control procedures including preparation and review of quality policies.
17. Become an active part of the site leadership team.
18. Assist and mentor wider teams/departments on local and global manufacturing Medical device standards.

Qualifications/Skills:

1. Ideally degree educated or possess similar practical expertise in Quality Management.
2. Quality Management experience within a licensed manufacturer of Medical Devices.
3. Internal/External audit expertise, preferably a certified internal auditor (although not a deal breaker).
4. People Management experience.
5. Ability to work on-site at least 4 days a week as this is a manufacturing role.

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