Quality Assurance Specialist

• Aug 2022 - Present

Board Member

• 1995 - Present

Foreningens formål: - at udbrede og forbedre kendskabet til anvendelsen af statistiske metoder fortrinsvis indenfor dansk industri - at formidle erfaringer vedrørende brugen af statistiske metoder til medlemmerne - at påvirke uddannelserne inden for foreningens område - at være forbindelsesled til beslægtede nationale og internationale organisationer Foreningens formål: - at udbrede og forbedre kendskabet til anvendelsen af statistiske metoder fortrinsvis indenfor dansk industri - at formidle erfaringer vedrørende brugen af statistiske metoder til medlemmerne - at påvirke uddannelserne inden for foreningens område - at være forbindelsesled til beslægtede nationale og internationale organisationer

Senior Quality Assurance Specialist

• Oct 2015 - Aug 2022

Administrator of the CAPA (Corrective and Preventive Actions) system and software for all employees globally: Responsible for SOP, instruction, training in CAPA principles and root cause analysis, training material for global use, sw validation, improvements Monthly CAPA board meetings with management Quarterly CAPA forum skype meetings with QA representative from Poland, US, and Mexico Coaching task holders and stakeholders re CAPA issues Software validation support

Quality Assurance Specialist

• Jul 2016 - Feb 2019

Administrator of sw for Corrective and Preventive Actions (CAPA) Responsible for SOP, instruction, Guideline, training, training material, improvement and validation of CAPA sw, support.

Quality Assurance Engineer (consultant)

• Oct 2015 - Jul 2016

In this project employment the goal was to close the overdue Corrective / Preventive Actions (CAPAs). When this was done, I had a list of improvements and corrections, which I had collected during my work with the CAPA software. And now, these have all been implemented, and we strive to have the sw validated before I leave as planned 1. July. It has been a fantastic meaningful and positive experience to learn about new products and have the opportunity to improve the tools that you… Show more In this project employment the goal was to close the overdue Corrective / Preventive Actions (CAPAs). When this was done, I had a list of improvements and corrections, which I had collected during my work with the CAPA software. And now, these have all been implemented, and we strive to have the sw validated before I leave as planned 1. July. It has been a fantastic meaningful and positive experience to learn about new products and have the opportunity to improve the tools that you work with. So when I leave, I am sure the users of the system will benefit from the more user friendly sw, and I will have had the best job ever!

Quality Excellence Specialist

• Mar 2006 - Jul 2022

Quality Excellence (QE) is a concept for optimizing the quality assessment in production with a holistic view and by use of lean tools. It is part of the Process Optimizing scheme of Coloplast. QE includes electronic data capture and handling using SPC, trend analyses, and other statistical tools.

Six Sigma Green belt holder

• Nov 2014 - Jun 2015

I have successfully completed my Six Sigma Green Belt education! It was about verifying if a test method (Dynamic Mechanical Analysis) was fit for its purpose: To test and release specific raw materials. It included planning and designing experiments, and use of statistical tools to evaluate and give evidence. Along the way, I also established improvements to the sample preparation and testing. It was a lot of work, but fun!

Quality Engineer

• Oct 2003 - Mar 2006

The job in QA department in Mørdrup was about: Evaluation and validation of methods of analysis Implementation of databases and software Contract Manufacturer audits, Development projects and root cause analyses

Lead Auditor

• Dec 2001 - Sep 2003

DGM is a notified body under Danish Standards Association (Dansk Standard) specialized in certification of Medical Device Producers. DGM certifies not only according to Quality Management Systems (ISO 9001 and 13485) but also Medical Device Directive and FDA requirements. DGM is a notified body under Danish Standards Association (Dansk Standard) specialized in certification of Medical Device Producers. DGM certifies not only according to Quality Management Systems (ISO 9001 and 13485) but also Medical Device Directive and FDA requirements.

Quality Assurance Specialist

• Aug 1989 - Jul 2001

Developing of brake pad linings. Test method setup. Life cycle analysis Manager of R&D laboratory. Raw Material Health and Safety Developing of brake pad linings. Test method setup. Life cycle analysis Manager of R&D laboratory. Raw Material Health and Safety

Board member of Occupational Group for Chemical Engineering

• 1989 - 2001

R&D lab manager

• Aug 1989 - Jun 2000

Roulunds produces brake pad linings for cars and trucks as well as various rubber products for transportation and environmental purposes Roulunds produces brake pad linings for cars and trucks as well as various rubber products for transportation and environmental purposes

Tutor of Clinical Technicians

• Jun 1980 - May 1986

The job consisted of planning, preparing notes for and teaching the students who - over 3 years - were trained as Bioanalysts (as they are now called). The topics: Physiology, biology, biochemistry, mathematics, The equipment: Autoanalyzers, HPLC, GC, blood count and ECG equipment, photometres, RIA, and some manual tests. The job consisted of planning, preparing notes for and teaching the students who - over 3 years - were trained as Bioanalysts (as they are now called). The topics: Physiology, biology, biochemistry, mathematics, The equipment: Autoanalyzers, HPLC, GC, blood count and ECG equipment, photometres, RIA, and some manual tests.