Director Quality Management Systems - MedTech (m/f)
Inseriert am: 18.02.2020
We are currently looking to recruit Director Quality Assurance to join a small team in MedTech industry. In this position, you will be reporting to the CEO.
Your responsibilities:
Aligning product lines with quality and regulatory standards and documentation
Conducting internal Q-audits and inspections
Assessing and communicating quality risks and regulatory risks as well as challenges to cross-departmental teams
Providing strategic focus aligned with US/European regulations
Monitoring and reporting on emerging trends and MedTech changes
Developing submission strategies for product in Switzerland
Building strong network and understand the Swiss MedTech market
Your profile:
University degree in Medical Engineering, Industrial Automation, Physics or Engineering
Work experience from industry based on ISO 13485 is a must
Fluent in German and English
Excellent knowledge of FDA, MDR/MDD, FDA, ISO 9001 and MDS
Collaborative mindset and solution-oriented spirit
Excellent written and oral communication skills
Willing to initiate continuous improvement processes
Excellent presentation skills
Proven organizational and analytical skills
Ability to interact at different hierarchical levels
Demonstrated skills in negotiations with suppliers or stakeholders
Collaborative leader and team player
Extraordinary strategic planner
Experience of working with Swiss Medic would be preferred
Are you knowledgeable in quality and regulatory standards in the medical devices industry? Are you looking for a new challenge? Do not hesitate to apply directly! We are looking forward to your application!
