Bartosz Pyssa Email & Phone Number

Poznań Area, Poland

Main responsibilities:- Managing team of Medical Devices Quality, and Validation Engineers as well as Quality Control and Incoming Inspection personnel (approx 17 staff in total)- Provide support for quality issues solutions (internal and external),- Ensure medical devices customer quality requirements are met,- Maintain compliance with branches regulations (FDA Part 820 and Part11, ISO13485, ISO9001),- Maintain validation process (meeting FDA standards),- Provide Quality Controls resources to support various manufacturing processes, incl. chemical laboratory (bio hazard),- Responsible for FDA Inspection.

Main responsibilities:- leading validation activities across processes in the company- development of validation process according to FDA and ISO in the plant