Quality Assurance Manager for Consumables- quality/ISO13485/FDA/german/english
Project / Role:
For our partner Roche Diagnostics in Rotkreuz we are looking for a highly motivated and qualified Quality Assurance Manager for Consumables
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. The candidate has to be willing to work in a fast changing and growing environment. The Operations Quality Assurance department consists of 35 people and the candidate will be working in a team of six, which covers the quality support of our consumables products. As a Quality Assurance Manager Operations the candidate will work with Global Operations to ensure that Roche procedures, applicable regulations and standards (regulatory requirements of United States Food and Drug Administration, In Vitro Diagnostics Directive of the European Union, ISO 13485, etc.) are followed during manufacturing.
• 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
• Academic degree in an 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.
Nice to Have:
• SAP Skills
• Knowledge of Injection Molding
Reference No.: 919977 AD
Role: Quality Assurance Manager for Consumables
Should you find yourself suitable for this position then please send us your complete CV using the link in this advert. If the position is not a perfect match and you wish to receive other opportunities directly, you can send us your CV anyway via this advert or to jobs[at]itcag[dot]com. Contact us for further information regarding our company, our positions or our attractive payroll-only-program: +41 41 760 77 01.
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.