Yllka Z

Quality Assurance Manager

Basel, Basel, Switzerland

About

Experience

  • Quality Assurance Manager at SKAN
    Feb 2024 - Present · 2 yrs 6 mos

  • Quality Assurance Specialist at Stryker
    Nov 2021 - Dec 2023 · 2 yrs 2 mos

    Key responsibilities : 1. Quality Management System • Facilitates change process and release of all procedures that require updates • Supports QMS compliance with the appropriate internal and external regulatory requirements • Identify improvements and inputs into the quality planning process. • Establish and maintain metrics and feedback mechanisms 2. Processing investigations of medical complaints • Determining the cause of complaint (root cause) • Perform a device inspection when possible or coordinate with the inspection cells • Introduction of necessary corrective measures (NC / CAPA) • Analyzing production documents, test certificates, risk assessments (risk management file), directions (Optech), processing instructions etc. • Creation of statistical analysis (Trending) • Documentation of complaint data and test results in the global complaint system • Connect with other department (R & D, manufacturing, RA, marketing, logistics, customer services) and attending meetings • Coordinate investigations on early product surveillance process • Provide necessary information to regulatory compliance team for reporting • Support the Manager Product vigilance in the department organization tasks 3. Quality Agreements • Help/support the process owner for process improvements • Coordinates the review and approval of Quality Agreements internally • Responsible for ensuring adherence to all external regulatory requirements

  • Glatfelter (Apprenticeship · 3 yrs 1 mo)
    • Project : Supplier Quality Management
      Sep 2018 - Aug 2021 · 3 yrs

      Management of a Supplier Quality Assurance project • Coordination of a project group in collaboration with the Quality, Purchasing, Production and Logistics departments • Monitoring of performance indicators 1. Qualitative evaluation - Appropriate procedures - Evaluation of the Quality impact while ensuring the follow-up with the suppliers 2. Supplier audit rules - Development of a procedure describing the audit process at a supplier - Audit report form 3. Follow-up of supplier complaints - Development of an internal tool for the management of complaints

    • Project : Quality Management Apprentice
      Aug 2018 - Aug 2019 · 1 yr 1 mo

      Key Responsibility : - Writing of quality documents (procedures, instructions, etc.) - Processing of customer complaints - Follow-up of corrective actions and measurement of their effectiveness - Analysis of indicators (KPI) - Participation in external audits including : - ISO 9001 : 2015 certification - FSC / PEFC ____ Project management : - creation of an PSM toolbox (Problem Solving Methods) : 8D, DMAIC, PDCA, Ishikawa diagram,5 Whys,.. - Animation of meetings and multi-disciplinary internal work groups, - Implementation of training plans.

  • Sales Associate at Dufry Group
    Jul 2019 - Jul 2021 · 2 yrs 1 mo

    Management of different shop • Selling a wide variety of products and services to the general public • Anticipating the customers’ necessities • Making assertive recommendations to customers based on their needs • Greet customers in a timely, professional and engaging manner • Build and maintain strong vendor relationships to maximize business results

  • Armani representative at Giorgio Armani
    Nov 2018 - Jun 2020 · 1 yr 8 mos

    Representation of the Giorgio Armani brand Axe Perfumerie & Cosmetics • Advice, application and sales of Armani products • Develop brand PDM by achieving daily objectives • Ensuring the visibility of a product range in the various departments • Apply the brand's commercial policy Launch new products • Monitoring and analysis of performance indicators Drafting of activity reports • Working knowledge of ISO 22716