Head Of Sales

• Jun 2022 - Present

Head of Quality Management & Regulatory Affairs

• Apr 2020 - Jul 2022

- Organization of the QA and RA team and strategic aligment- Coordination of Quality Assurance activities for 30+ internal and external development projects - Setting up the international Regulatory Strategy for active medical devices (class IIa,b, III)- Responsible for QMS and product certification according MDR- Improvement and strategic alignment of Systems Testing team

Person Responsible for Regulatory Compliance (PRRC)

• Apr 2020 - Jul 2022

Quality Management Representative

• Aug 2019 - Jul 2022

- Quality Management System Maintenance and Development (13485:2016, 21 CFR 870, MDR)- Mecial Device Safety Officer according to MPG §30 - Complaint Handling - Auditing internal / external- Quality Support in projects with focus on cardiovascular applications

Quality Manager

• Jan 2018 - Apr 2020

Quality Management, Validation (Process and Software), Risk Management, Changemanagement of business processes- Maintenance and further development of the existing QM system according to ISO 13485:2016 and MDR- Analysis, (re) design, optimization, documentation, support in the implementation and training of processes- Cooperation in the operative implementation of the quality policy- Creation of approval documents / QA project support- Maintenance of the entire QM documentation- Conducting risk analyzes- Follow up preventive and corrective actions Show less

Production Engineer

• Apr 2017 - Dec 2017

- Planning of operations and procedures- Development support regarding manufacturability- Incorporation and guidance of new employees- Creation of assembly and test instructions- Creation / programming / selection of testing software- Assembly / testing of medical devices

Working Student

• Jul 2015 - Jan 2016