Document Control and Training specialist

· Document Control- manage and maintain company-controlled documents both electronically and manually, maintain logs for QMS implementation etc.

· Perform training to new employees, manage professional training for employees in the Grand Avenue Software system and follow-up employees’ qualifications.

· Organize and coordinate submissions/applications to various regulatory and organizations.

· Establish and ongoing updates for QMS procedures & work instructions according to EU MDR and MDSAP requirements.

· QA representative in design control for regulatory compliance.

· Ensure Quality Systems activities are implemented and maintained to satisfy FDA GMP/QSR, ISO 13485, MDR, MDSAP and applicable local regulatory requirements.

Essential Duties, Education, Experience and Skills:

· 1-2 years of experience in a Quality / Regulatory function within the medical device company.

· Knowledge of applicable Quality System regulations, such as GMP/QSR, MDR and ISO 13485.

· Very good English skills %28speaking, reading, and writing%29.

· Organized and Detailed orientated

· Team Player

· Proficient in Excel & Word; ability to learn various documentation software