QA Manager
Roles and Responsibilities
• Responsible for Hearing aids framework regarding to medical device directive (Council Directive 93/42/EEC)
• Responsible for Hearing aids functionality according to ISO 13485 standard
• Responsible for Hearing aids functionality regarding to risk management medical devices process ISO 14971 standard
• Establishment of risk management process team and acting as “Process manager”
• Setup bi-weekly risk management process team meeting + MOM
• Assisting in planning the schedule and scope of the company critical supplier audits according to ISI 13485: 2016 (4.1.5 Control outsourcing)
• Critical supplier audit report and follow up
• Data validation and verification of Hearing aids according to ISO 13485 standards
• Working with technical file
• IEC 62304 (SW), IEC 60601 (HW), ISO 10993 (Biocompatibility), IEC 62366 (Usability)
• Working with clinical evaluation process and report (MEDDEV 2.7.1, Rev 4)
Achievements:
• Phase 1: Q2 2018 (assesses the maturity of the quality management system.) ? BSI visit to the business to review the status of the organisation, system documentation and infrastructure.
• Phase 2: Q3 2018 (ready for CE marking) ? BSI visits for the certification audit aiming to verify that the system documentation meets the requirements of ISO 13485 standard.
• Set up and running risk management medical device process ISO 14971