QualityVision
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.
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
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CVR-nr.: 27 80 11 61
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