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QARA Leader - Zug

QARA Leader - Zug

Vacancy Overview

My client is a medium-sized, internationally active family business in the field of medicine and Health based in the Canton of Zug and own subsidiaries in 5 countries.

The development and production of their own products characterizes them nationally and internationally.

They are looking for an immediate or by appointment Head of Quality Management and Regulatory Affairs

The following tasks belong to your exciting field of activity:

Responsible for Quality Management (QM) and Regulatory Affairs (RA)

Maintenance and further development of the quality management system (IQSoft)

Implement and monitor measures to comply with the relevant

Norms and Laws

Support of the operator in the implementation of the Medical Device Operator Ordinance (MPBetreibV)

Management Representative to the FDA

Assisting and advising process owners in designing the

Processes / Interfaces

Provide key figures and elaborate improvement measures

Assist and advise on sales, production and other jobs

Complaints, Quality-Related Topics, Audits and Regulatory Affairs

Responsible for auditing and certification in accordance with applicable standards

To act as the MDR representative and to lead the QARA team.

Experience Required

Basic technical training with advanced training in quality management

Well-founded, multi-year experience in Quality Management and Regulatory Affairs, preferably in medical technology

Entrepreneurial and acting person

goal-oriented and results-oriented as well as analytical and conceptual thinking

Structured working with organizational skills and the ability to work independently and nevertheless to work in a team-oriented manner

Very good know-how in project and process management

Fluent German / English in spoken and written, other languages ??are an advantage

Versatile, curious, customer-oriented and likes to lend a hand