Jacob Hansen Email & Phone Number

Copenhagen, Dk

Sjælland, Danmark

Danmark

Denmark

• GMP - ISO 13485 & US 21 CFR Part 11 Compliance• Interfaced cross-functionally with Engineering, Manufacturing and Sourcing to ensure production transfer of products are in accordance with company procedures.• Planning, coordinating, and managing the quality assurance activities associated with multiple Product Development (PD) projects to ensure compliance to internal (FDA) and external requirements (ISO) during the production and commercialization of products.• Participated in compliance walks with emphasis on meeting QMS(quality management standards)

Ballerup

Lead, Motivate and Develop -I lead a team of managers, who are responsible for international projects, negotiate and implement quality contracts in close collaboration with our Corporate Procurement as well as the continuous monitoring of supplier performance including planning improvements.I ensure that handling, release and distribution of the products are in accordance with regulatory and legislative requirements, GMP/GDP and the Getinge Quality Manual.I act as the Chairman of the CAPA Board at Getinge Denmark, Monitoring CAPA actions and timeliness. Assign handlers, Initiate and forward product complaints according to procedures. Investigate, Maintain and perform reports with evaluations from trend analysis. Furthermore I contribute to implementation and maintenance of Getinges Corporate Quality Manual, and assure our compliance by internal audits.

Hillerød

Sikring af Compliance iht. FDA. mm. iht. processer, produktion og dokumentation. Godkendelse eller terminering af ovenstående i forskellige projektgrupper. Udfører review og trending af CC-sager.Agerer desuden i CSG- Complaint Surveillance Group for både Prefilled & Durable hvor vi vurderer, trender og reviewer CSG' sager.

Århus

Ledelse af projekter, herunder forsknings-, udviklings- og implementeringsprojekter i en organisation med mange snitflader.Projekt-ledelse med udvikling af MathLab-program "Tremble" til generering af data udfra PET-scanninger i samarbejde med CFIN og Københavns Universitet.Optimering af operationsgangen for eksisterende indopererede Pectus-barre til thorax-afdelingen ved Skejby Sygehus i samarbejde med Hans Pilegaard.

Cand.Scient.Med., Biomedical/Medical Engineering

Aarhus University, Cand. Scient. Med. - Biomechanical Engineering

Bachelor'S Degree, Mechanical Engineering