Drive Quality Excellence: Join Our Life Savers Team as a QMS Specialist Today!
The Quality Management System Specialist is responsible for supporting the Senior Manager of Quality Management in the successful implementation and maintenance of the Quality Management Systems (QMS) , with a focus on Training, Documentation Control, Change Management, CAPA and Quality Audits (both internal and external). The specialist collaborates with relevant quality departments or functions at system houses to ensure alignment with the Quality System.
Your Responsibilities
- Support the site’s Quality Management Representative to ensure compliance of the QMS with relevant medical device regulations.
- Provide training and hypercare to users on QMS related system such as Document and Change Control Management System, Learning Management System, CAPA/Deviation Management System.
- Ensure the sustaining of training administration through Learning Management system, assigning required training based on process and developmental needs.
- Ensure the execution of training for quality processes and quality awareness , including new hire orientation.
- Coordinate with different departments to gather data for supporting cockpit card KPI reporting in management review meetings.
- Maintain quality documentation using the electronic documentation control system.
- Ensure the archival and retrieval processes of Quality Records (e.g. DHR) are maintained according to requirements.
- Ensure timely distribution and retrieval of controlled documents to and from users and functions.
- Administer and manage CAPA, change review and control management for the site, coordinating with system house when required.
- Administer and manage Change Control Review and Management in close collaboration with all stakeholders, coordinating with system house when required. Ensure proper capture, review, deployment, and documentation of all QMS and Design/Process changes.
- Coordinate CAPA activities and facilitate site CAPA Review Board meetings, collaborating with all stakeholders and coordinating with system house when required.
- Assist the Senior Manager of Quality Management in planning and executing both internal and external audits, including the management of audit findings.
- Assist with QMS improvement initiatives as needed.
- Support and execute projects, as well as other quality-related activities directed by the supervisor.
Your Profile
- Technical or scientific degree from a college or university (e.g. mechanical engineering, biomedical engineering, polymer engineering, natural sciences)
- Two to five years of work experience in a quality function within a regulated environment (e.g. medical devices or pharmaceutical industry)
- Knowledge of cGxP and QMS regulations: ISO 13485 and FDA 21 CFR 820.
- ISO 13485 auditor certification
- Experience as lead or auditee in third-party audits (FDA, Notified Bodies, Competent Authorities) is preferred.
- Proficiency in desktop applications, analytical tools, presentations and document management.
- Management of document and quality records lifecycle.
- Good communication skills with individuals at all organizational levels.
- Fluent in English (spoken and written); German language skill is a plus.
- Experience using SAP and Aras PLM is a plus.
