Quality Manager – Digital Medtech
· Lead the quality management and quality assurance (process compliance) activities.
· Create and maintain technical product files.
· Supervise vigilance processes.
· Support product development from a quality perspective
Quality Management System
· Implement and maintain of the Quality Management System(s), including team training for QMS.
· Support QMS certification
· Support QMS audits
· Process ownership of specific QMS procedures
· Responsible for managing QMS trainings.
· Responsible for managing the CAPA process including planning, monitoring, and closure.
· Create and maintain regulatory files, including technical files for the company’s products.
· Participate in product risk management activities and maintain product risk files.
· Ensure compliance of technical documentation to regulatory requirements, such as MDR
· Review and release of product design and development documents
· Product classification and conformity assessment
· Maintain, control, and improve the QMS.
· Check the adherence to quality standards.
· Responsible for supplier management and outsourced processes
· Participate in audits.
· Monitor and report product and process KPI
· University degree
· 3+ years’ work experience in medical device industry or similar
· Strong experience in QMS, Quality Assurance and technical documentation of medical devices or similar
· Experience in the development of software medical devices or similar
· Knowledge about medical standards and regulations like 13485, 14971, 62304, 62366, MDD, MDR, FDA QSR