Our client, a leading medical diagnostics company in Zug area, is looking for aQuality Assurance Manager for Consumables
Starting date: asap latest 01.05.2021
Contract: 6 months with possibility of extension
Home Office: during corona time
The Consumables Quality Team is looking for a highly motivated and committed Operations Quality Assurance (OpsQA) Manager with experience in the product care of medical devices / IVDs.Main Tasks:
- Support and enable our business partners during a time of increasing production volumes and regarding product care and product improvement activities as well as in all other quality aspects of our consumables products
- Ensure product quality and compliance to the regulatory requirements and the proper documentation of all activities
- Support our business partners by: Reviewing and approving documents, changes, deviations, Reviewing and approving Q&V activities and Releasing Products
- Ensure improvements through CAPAs, SCARs and process updates
- Lead and/or support special projects or initiatives in the area of quality and of our business partners
- Permanently optimize processes in order to increase quality and efficiency standards
Nice to Have:
- Academic degree in a engineering or life science discipline
- At least 5 years of practical experience in Quality Management, Quality Assurance or Quality Control (*****)
- At least 5 years of professional experience with the medical device regulations including ISO 13485 and FDA regulations for the above-mentioned processes. (*****)
- First experience in leading process improvement projects. (*****)
- First experience with stakeholder management across all hierarchy levels. (*****)
- An active and initiative personality as well as strong communication skills in both German and English.
- You excel in a demanding interface role in a complex environment and have a solution-oriented mindset.
- You describe yourself as self-dependent, structured, quality oriented and determined.
- You contribute crucially to the spirit of the existing team.
- SAP Skills
- Knowledge of Injection Molding
Randstad (Schweiz) AG