Our site in Zug is looking for a talented Quality Systems Supervisor!
SCOPE OF THE ROLE AND BASIC PURPOSE
As Quality System Supervisor for ASP Division of Cilag (ASP Europe / ASP EMEA) ensure development and implementation of quality systems in compliance with established standards.
KEY RESPONSIBILITIES / TASKS (indicate estimated % of time spent where possible)
1) Management of ASP EMEA documents. (Including alignment of J&J & MD procedures)
2) Supervise the training process for ASP EMEA staff
3) Management of ASP EMEA Key Process Indicators
4) Supervise and host internal audits
5) Organize and facilitate third party audits of ASP Europe
6) Organize and facilitate ASP Europe Management Reviews
7) Lead other projects as assigned by manager
ACCOUNTABILITIES / KEY MEASURES
ASP Europe compliance to internal and external requirements – Obtain and maintain ISO 13485 and FDA registration for ASP Europe.
ASP Europe compliance to Enterprise and Sector Standards.
Qualifications
BS / BSN degree (science or engineering preferred) with 3 to 5 years related experience.
Training of medical device regulations to include ISO 13485 and 21 CFR 820 minimum
