QMS Specialist

• Oct 2021 - Present

• Apr 2019 - Sep 2021

Managing the implementation of ISO standards, medical directive in the EU and FDA for the US market. Procedure establishment, documenting and communication within the organization. Organize and perform internal audits. Actively participate in meetings with the management team. Managing medical regulation device requirements and regulations related to medical software development.Standards experience includes:ISO 13485:2016 - Medical devices - Quality management systems — Requirements for regulatory purposesISO/IEC 27001:2013 - Information technology — Security techniques — Information security management systems — RequirementsISO 9001:2015 - Quality management systems — RequirementsEN ISO 14971:2012 - Medical devices - Application of Risk Management to MedicalDevicesIEC 60601-6:2010, AMD1:2013 - General requirements for safety – Collateral Standard: UsabilityEN IEC 62304:2006 - Medical device software - Software life-cycle processesEN IEC 60601-2-47:2012 - Medical electrical equipment - Part 2: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systemsIEC/TR 80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software Show less

• Apr 2019 - Sep 2021

Containing the following duties and responsibilities:- Test products (ECGalert, Gluco, ViewHRV) and identifying deficiencies- Suggest solutions to identified product problems - Investigate product quality in order to make improvements to achieve better customer satisfaction- Plan, create and manage the quality assurance documentation- Collaborate with the Software Development team to ensure consistent project execution- Identify quality assurance process bottleneck and suggest actions for improvement Show less

• Feb 2018 - Mar 2019

Successful implementation of:- ISO/IEC 27001:2013 - Information technology — Security techniques — Information security management systems — Requirements- ISO 20252:2019 - Market, opinion and social research, including insights and data analytics — Vocabulary and service requirementsProcedure establishment, documenting and communication within the organization. Organize and perform internal audits. Actively participate in meetings with the management team.

• Feb 2018 - Mar 2019

Responsible for processing large amounts of data. Everyday tasks include doing data entry work, organizing and cataloging data, doing quality control inspections, solving technical problems, and offering support to other employees.

Patient Services Supervisor

• Nov 2014 - Jan 2018

Supervision of the Patient Services Department consisted of around 30 employees. Organize workflow and ensure that employees understand their duties or delegated tasks. Mentor and educate new employees. Receive complaints and resolve problems. Participate in implementation of outsourced projects, as well as being part of committees and management meetings. Supervision of the Patient Services Department consisted of around 30 employees. Organize workflow and ensure that employees understand their duties or delegated tasks. Mentor and educate new employees. Receive complaints and resolve problems. Participate in implementation of outsourced projects, as well as being part of committees and management meetings.