Responsible for technical documentation connected to the medical device to ensure safety and appropriate quality for the product range.Accountable for Design Control, Change Control and Risk Management for products within the product portfolio.
Handling regulatory requirements according to FDA, MDD, GMP, ISO standards, etc.Defining and taking responsibility for the Post Market Surveillance of launched products.Supporting local markets with technical product expertise and data for tender requests.Managing major improvement projects (Black Belt certification).Participating in product development projects.Performing validation according to PPAP, IQ/OQ/PQ, Six Sigma, etc.