Eindhoven, North Brabant, Netherlands
Result-oriented, multi-discipline process improvement management, problem solving, change management. organisational change, risk management, people management, coaching for improvement and higher performance. 21 CFR 820, ISO13485:2003/2016, ISO14971:2012/2016, MDSAP, Lean improvement, Agile development, SCRUM
- Coach/advise product development and related teams on correct and compliant processes application - Manage resolution of complex and long running CAPAs. - Manage and facilitate multi-discipline improvement / change projects - Auditing of implementation of business processes. - Assessment of organisational compliance to 21CFR 820 and ISO13485:2016 standards
- Activity planning - Team buildup and coaching - Develop team skills and competence training plan - Identify essential improvements required to improve execution of business processes. - Coach/advise product development and related teams on correct and compliant processes application. - Support partner company to implement their QMS and introduction of Agile methodology.
- Management of multidiscipline projects for innovative products. - Introduction of Agile/SCRUM activities in existing SW Engineering team. - Management of activities required for successful introduction to the market.
- Team growth and development - Competency management of SW group members. - Coaching team members.
- Resource pipeline management - Competence Development/Replacement management - Project Management of multi-discipline project (Hardware, Software, Marketing, Logistics, Customer Support) responsible for new product creation.