• Lead Global monitoring of the Non-Conformity and CAPA processes performances, trending and reporting on global KPIs as input to the global CAPA Board and Corporate management Reviews.
• Lead Global CAPA meetings and ensure global records are up to date, act as CAPA coordinator.
• Support the quarterly KPI review preparation.

• Document Control incl. ensuring:

• Proper document layout,
• Coherence to the QMS structure,
• Proper review and approval in the electronic document management system,
• Compliance to relevant standards and regulations,
• Training material updates and training assignments,
• Publication and communication of changes.

• Record Control:

• Establishment and handling of quality documentation and records, incl. completion follow-up, review and archiving.

• R&D equipment calibration support including maintaining Calibration schedule, reviewing and approving calibration reports.

• Support the global monitoring and qualification of the Service Suppliers used in HQ.
• Ensure reevaluation are done on time.

• Participate in quality planning and follow-up to ensure documented completion of activities.
• Follow-up on implementation of new QMS documents and potential concessions.
• Ensure QMS activity schedules are adhered to, e.g. quarterly reporting, monthly trending, audit schedules, periodic reviews, etc.

• Quality related improvement projects.
• Internal and external audits.
• Maintenance of information to be published on the Intranet.
• Other ad hoc coordination and admin activities.

• Academic degree or equivalent.
• Excellent proficiency in MS Word, Excel, Power Point and Teams.
• Experience working in a regulated environment, such as the medical device industry, and according to standards and regulations, such as ISO 13485 and EU Medical Device Regulation is an asset.
• Strong verbal and written communication skills in English.