Curriculum Vitae
Tom Andersen QualityVision Konsulent til medical device pharma og biotek


Owner and Principal Consultant Tom Andersen

Experienced QA person with more than 25 years of experience in life science.

I have experience in medical devices, pharmaceuticals and biotechnology.

Since 2001, I have mainly worked with medical devices.

I have extensive knowledge of cGMP and in-depth process understanding within quality management systems in life science [ISO9001, cGMP, ISO 13485, 21 CFR 210, 21 CFR 211, 21 CFR 820].

I have management experience from QA and production.

My experience and personality make me a flexible partner who has the opportunity to offer companies exactly the advice and service that suits the company.

Download my CV and feel free to contact me for a non-binding talk.

Visit my LinkedIn profil

Competencies and experience

  • Quality manager and management representative
  • Certified Lead Auditor (performed + 80 audits according to ISO 13485 and ISO 9001)
  • Project Manager I Validation Manager I Risk Manager

  • Implement, organize and improve QMS systems, and ensure that they are in compliance with applicable regulatory requirements.
  • Implementing Risk Management according to ISO 14971
  • Interaction with competent authorities, notified bodies and customers
  • Validation I Qualification I Commissioning
  • Supplier management
  • Performed nummerous of courses and education in quality related topics (more than 1000 hours)
  • Management and communication in international environments
  • Preparation of Gap Analysis (ISO 13485, FDAcfr820, ISO 9001)
  • Identification and implementation of corrective and preventive actions as well as continuous improvements
  • Implementation of documented change control

Selected technologies & processes:

  • Plastic processing (IVDR products Class I & II)
  • Metalworking (MDR products Class II)
  • Ostomy products, hearing aids, dental implants, laboratory products, cell culture products
  • Production in clean rooms, sterilization