Quality Manager – Digital Medtech

​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

Responsibilities

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.

Technical documentation

·       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

Quality assurance

·       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

 Qualifications

·       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

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