Experience

TeesuVac ApS

• Denmark
• Medical Equipment Manufacturing
• 1 - 100 Employee

• QA/RA Director

  • Aug 2022 - Present

  https://www.linkedin.com/company/teesuvac-aps/ https://www.linkedin.com/company/teesuvac-aps/



Visiana

• Denmark
• Medical Equipment Manufacturing
• 1 - 100 Employee

• QA/RA Manager

  • Jan 2022 - Jul 2022

  - Maintaining the effectiveness of the eQMS. - Product realization - Handling documentation packages for FDA /Notified Body and other authorities. - Communication with representatives for different countries. Job Specific Roles & Responsibilities: - Create, edit and modify documentation so that the company meets the requirements of external standards. - Review and approval of controlled documentation - Plan and facilitate internal audits. - Main responsibility for handling the CAPA process. - Main responsibility for risk management. - Preparation for company meeting MDR requirements. - Assist development in doing usability engineering on company developed products meant for external use. Show less



Qufora

• Denmark
• Medical Equipment Manufacturing
• 1 - 100 Employee

• QA Specialist

  • Aug 2020 - Dec 2021

  Ansvarlig for reklamationer, afvigelser, SCAR's, CAPA's. Audit' s. QA repræsentant i R&D Design Control. Godkendelse af kalibreringer og modtagekontrol. Document controller. Ansvarlig for reklamationer, afvigelser, SCAR's, CAPA's. Audit' s. QA repræsentant i R&D Design Control. Godkendelse af kalibreringer og modtagekontrol. Document controller.



Sigma Connectivity

• Sweden
• Telecommunications
• 200 - 300 Employee

• Seniorkonsulent

  • Dec 2019 - Aug 2020

  MDR opdatering af design documentation. MDR opdatering af design documentation.



ÅF

• Sweden
• Civil Engineering
• 700 & Above Employee

• Senior QA Engineer

  • Oct 2016 - Nov 2019

  DQ, SAT, IQ, OQ, PQ protokoller og rapporter. CR Sager. VNC´er, SOP skrivning. QA support for produktionsteam. DQ, SAT, IQ, OQ, PQ protokoller og rapporter. CR Sager. VNC´er, SOP skrivning. QA support for produktionsteam.



Pharma4ever A/S

• Denmark
• Business Consulting and Services
• 1 - 100 Employee

• Senior Consultant

  • Nov 2015 - Sep 2016

  IQ, DQ, SAT protokoller og rapporter. CR Sager. VNC´er. GMP dokument implementering hos ikke GMP leverandør IQ, DQ, SAT protokoller og rapporter. CR Sager. VNC´er. GMP dokument implementering hos ikke GMP leverandør



AlfaNordic - full part of the NIRAS Group

• Denmark
• Business Consulting and Services
• 1 - 100 Employee

• Consultant

  • Dec 2014 - Oct 2015

  Document manager on new package line Optimization of Casepacker Document manager on new package line Optimization of Casepacker



Convatec Infusion Care

• Denmark
• Medical Device
• 200 - 300 Employee

• Quality Assurance Coordinator / Artwork and Labeling Project Manager

  • Aug 2013 - Nov 2014

  Responsibility: • RA documentation • Change request • Handling Complaints from customers • Specifications Responsibility: • RA documentation • Change request • Handling Complaints from customers • Specifications



PMC Hydraulics A/S

• Denmark
• Automation Machinery Manufacturing
• 1 - 100 Employee

• Quality Assurance Project Coordinator

  • Jul 2011 - Jul 2013

  Responsibility: • Internal and external Audits • Handling Non conformities • Handling Complaints from customers • Handling 8D reports • SOP handling • Making training in SOP´s and Audit´s • FMEA • Production Support for prototypes and production. Responsibility: • Internal and external Audits • Handling Non conformities • Handling Complaints from customers • Handling 8D reports • SOP handling • Making training in SOP´s and Audit´s • FMEA • Production Support for prototypes and production.



Siemens Healthineers

• Hospitals and Health Care
• 700 & Above Employee

• QM Coordinator

  • Mar 2007 - Jun 2011

  Responsibility: • CAPA • Internal and external Audits • SOP handling • Handling Non conformities • Q-Gates • Certificates of release for customers • Validation - IQ, OQ, PQ, FAT • Production Support for prototypes and production • Connection between supplier, design and production. Responsibility: • CAPA • Internal and external Audits • SOP handling • Handling Non conformities • Q-Gates • Certificates of release for customers • Validation - IQ, OQ, PQ, FAT • Production Support for prototypes and production • Connection between supplier, design and production.



Danfysik A/S

• QA Coordinator

  • 2007 - 2011



MediCult / Origio

• QA Coordinator

  • Feb 2004 - Feb 2007

  Responsibility: • Calibration and service of equipment • Internal and external audits • Batch documentation • Handling Non conformities • CAPA • Change request • SOP handling • Handling Complaints from customers • Validation • Qualification Responsibility: • Calibration and service of equipment • Internal and external audits • Batch documentation • Handling Non conformities • CAPA • Change request • SOP handling • Handling Complaints from customers • Validation • Qualification



Pharma-Vinci A/S

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• QA Assistant

  • 2000 - 2004

  Responsibility: • Batch documentation • Handling Non conformities • Stability tests • Contact with authorities • Internal and external audits • Change request Responsibility: • Batch documentation • Handling Non conformities • Stability tests • Contact with authorities • Internal and external audits • Change request