Anna N. Email & Phone Number

Wrocław, Pl

- Supervision of EMEA AFAB (Aligner Fabrication) QMS team- Coordination of certification audits- Implementation and execution of an internal audit program- Approval and confirmation of corrective and preventive actions- Managing QMS department activities from the policies and procedures creation to their execution- Supporting the respective departments with problem-solving and/or continuous improvement activities- Giving direction to, and coordinating activities with the different process owners to ensure the effectiveness of the QMS in the AFAB manufacturing facility- Ensuring that the QMS activities are consistent with the standards and regulations for medical devices included in the scope of the company Quality Manual- Led a project of the MDSAP (Medical Device Single Audit Program) implementation in the AFAB facility- Acting as an EMEA internal lead auditor

- Supervision of QMS Coordinators (5 specialists)- Strategic decision-making in the activities of the HCBG QMS team - Coordination of tasks and defining goals for employees and department- Coordination of customer and certification audits- Preparation and conducting of management reviews- Conduct appraisals which focuses on the teams performance, training and career development- Responsible for implementation and maintenance of all applicable regulations and standards, along with the requirements from the global team (QMS processes standardization) - Approval and confirmation of corrective and preventive actions

- Managing the QMS in the HCBG divisions- Supervising the work of the HCBG QMS team - Ensuring compliance with the requirements of ISO 9001 / ISO 13485 / FDA and all legal requirements applicable in the HCBG divisions- Cooperation with the production and other supporting departments to maintain and improve the QMS- Conducting training sessions- Promoting the idea of continuous improvement of the QMS

- Internal & external audit coordinator: preparation and supervision of the annual audit programmes; define the audit criteria and scope for each audit; on time/in full audit monitoring; improving internal auditors qualifications; ensuring that the results of the audits are reported to relevant management- Company representative during customer and notified body audits - Conducting internal and external audits- Responsible for corrective and preventive actions (process standardization)- Preparation and conducting of management reviews- Preparation of quality documentation (Quality Manual)- Increasing knowledge and quality awareness through conducting trainings and workshops

- Monitoring and management of documentation, records and internal training database- Conducting process and product audits (nonconformity detection)- Reporting of KPI- Leader for Internal Trainings Process Improvement project (Medical Division)- New Training Database Implementation leader (Food Safety Division)- Team member of ISO 13485:2016 transition project

Master Of Science - Ms, Faculty Of Chemistry, Spec. Physicochemical Basis Of Nanotechnology

Bachelor'S Degree, Chemistry