Minimum 2 years of experience in Quality Assurance and/or Quality Control within the Medical Device industry. medisana GmbH is one of the leading specialists in the home health care market. You want to grow professionally, take responsibility, and contribute to the quality of innovative medical and wellness products. Then join our Quality Management & Regulatory Affairs team in Neuss and help us make a real impact as our Quality Management System (QMS) * Author and revise Standard Operating Procedures (SOPs) and quality system documentation in line with ISO 13485 and EU MDR 2017/745 requirements. * Support the closure of Non-Conformances (NCs) following internal audits, gathering evidence and completing the required quality records. * Prepare and organise quality documentation and records ahead of and during internal audit days. Product Quality Control – Class IIa Medical Devices
Minimum 2 years of experience in Quality Assurance and/or Quality Control within the Medical Device industry. medisana GmbH is one of the leading specialists in the home health care market. You want to grow professionally, take responsibility, and contribute to the quality of innovative medical and wellness products. Then join our Quality Management & Regulatory Affairs team in Neuss and help us make a real impact as our Quality Management System (QMS) * Author and revise Standard Operating Procedures (SOPs) and quality system documentation in line with ISO 13485 and EU MDR 2017/745 requirements. * Support the closure of Non-Conformances (NCs) following internal audits, gathering evidence and completing the required quality records. * Prepare and organise quality documentation and records ahead of and during internal audit days. Product Quality Control – Class IIa Medical Devices