Deutsche Augenoptik GmbH (DAO) – HOYA Lens Deutschland GmbH
Successful implementation including initial and follow-up certification of the QMS, maintenance and further improvement of the quality management system for medical devices such as eyeglass frames, lenses, sports glasses and equipment in the ophthalmic field Class I and IIa according to EN ISO 13485:2021 and EU-MDR 2017/745
Analysis and improvement of processes to ensure and enhance a modern and future-proof quality management system
Supported implementation of management objectives in quality, environmental protection and health
Conducted trainings for continuous implementation of quality mindset
Performed internal audits and supported external audits, including communication with authorities and reporting of incidents
Assisted with technical documentation
Additional roles: data protection coordinator to the external data protection officer, safety officer for occupational health and safety including ASA meetings, whistleblower officer – case manager (Whistleblower Protection Act)
Part-time support/services in quality management/quality assurance, as well as in health, occupational safety, sustainability, environmental protection, data protection, and AI
Development and maintenance of management systems including IMS
Quality management and documentation
Complaint and supplier management
Quality planning, quality assurance
Conducting internal audits and supporting external audits
Process optimization
Project management
Implementing artificial intelligence (AI) in document management
Corporate health management
Applied standards/regulations: ISO 9001:2015, ISO 13485:2021, ISO 14001:2015, IATF 16949:2016, VDA ISA (TISAX), VDA 6.3, GDPR, MDR, QM-RL / G-BA
Clients in dental technology, software development, stamping-plastics technology, turning/milling technology, electrical engineering, technical development
Current activities: QMR at Albdental Dental Clinic in Karlsbad-Ittersbach, Quality Technician / QMR / Environmental Management Representative at CarMedialab in Bruchsal
Responsible for further development, monitoring and design of the quality management system according to ISO 9001:2015 and TISAX Level 3 with prototype protection and data privacy
Planning, conducting and follow-up of audits
First point of contact for employees and customers on all relevant quality management topics
Creation, review, modification and maintenance of documents
Ensuring compliance with quality standards
Conducting internal training sessions independently
Data protection coordinator for the external data protection officer
Dec 2019 - Nov 2020
1 year
Ingersheim, Germany
Quality Planner (Full-time)
ACPS Automotive GmbH (ORIS)
Advanced quality planning for passenger car towing devices and ORIS bicycle carriers at the development and prototype site according to ISO 9001 and IATF 16949
EMPB / PPAP / PPF / D-FMEA / APQP / control plan creation
Risk analyses, quality reporting on customer platforms
Complaint and supplier management
Field damage part analysis according to VDA QMC
Tracking quality targets and coordinating quality management measures
Providing support for manufacturing plants worldwide