Quality Systems & Compliance Expert - Solothurn, Switzerland

Quality Systems & Compliance Expert - Solothurn, Switzerland

Skills -

Strong knowledge of quality and compliance for Medical Device Industry (GMPs).
Working knowledge of Quality System Regulations.
A good working knowledge of related functions such as Operations, Supplier Management, Product Development and Procurement
Experience in FDA QSR and ISO 9001/ISO 13485 standards, additionally a working knowledge of PAL and other related medical device national regulatory standards
Demonstrated knowledge of business impact of compliance issues and risk management
Proven ability to build partnerships both internally and externally
Strong collaboration and influencing skills to partner effectively with various functions and across Operating Units - Both Internally and Externally
Expert knowledge of the US Quality System Regulations and ISO 13485
Demonstrated track record of delivering best in class results in the Quality Systems area
The ability to independently execute risk assessments and remediation activities
Fluent in German and in English - able to review CAPA & sub-system data and documents & interact with Quality Management & site process SMEs

Role - Perform remediation activities generated from the Management Review Legacy Reviews to ensure adequate product and process risk review.
Perform Management Review remediation per schedule.
Access product and process risk and alert management of product quality & compliance issues for proper and timely escalation to CAPA.
Engage with local Quality Management and site process SMEs to ensure adequate actions are taken.
Provide support for documentation of remediation activities.
TO ADHERE TO THE COMPANY'S PROCEDURES AS DETAILED IN THE SOP MANUAL