Join Tecan! Join the market leader!
Ever wondered how your skills and unique background could impact the world of tomorrow? Join our Quality team and bring your passion and talent to work.
Quality Systems Manager
Männedorf, Switzerland
Your contribution
As a dedicated and experienced “can do” Quality Systems Manager at Tecan Schweiz AG, you are an integral partner to maintaining and enhancing our mature local and global Quality Management System and you are promoting a culture of quality and compliance across the organization. The successful candidate will be responsible for the local monitoring and improvement activities including local documentation, and you are responsible for our CAPA process, conducting, supporting, and driving root cause investigations, and supporting local and global QA/RA initiatives.
Responsibilities
- Maintain and continuously improve the local Quality Management System.
- Act as a change agent to implement, monitor and improve local T-CH processes.
- Manage the local CAPA process, ensuring KPI`s are met and reported to management.
- Conduct/Support and drive Root Cause investigations for CAPA/Complaints/Product NCR.
- Support global document control and document training process where needed.
- Act as Quality culture ambassador and support management review activities.
Your background
We’re not just looking for hard skills: We’re looking for people who bring their passion and talent to work.
- Education or degree in Life Sciences, Engineering, or at least 5 years of experience in quality management or regulatory affairs related to MDR or IVDR.
- Extensive knowledge of quality management systems, particularly ISO13485:2016.
- Proven experience in managing Corrective and Preventive Actions (CAPA) within a regulated environment.
- Experience in conducting Root Cause investigations using proven methodologies or lean/6 sigma.
- Ability to develop, implement, and maintain quality systems for compliance and continuous improvement.
- Proficiency in risk management and root cause analysis.
- Exceptional communication skills for conveying complex information clearly.
- Excellent problem-solving skills with a proactive approach.
- Strong leadership and team management abilities.
- Minimum of 5 years of experience in quality management roles within the IVD or medical device industry.
- Proven track record of managing CAPA processes and driving quality improvements.
- Experience in leading cross-functional teams and projects.
- Proficiency in English and German; additional languages are a plus.
What makes working at Tecan unique
The chance to make it count and to have an impact on the world of tomorrow
- Working in an international and diverse environment
- The chance to grow your career within the company
- Feel empowered by our strong and unique company culture
- Comprehensive compensation and benefits package
Join Tecan, a great place to work! Read about our recent certification from Great Place to Work.
We’re looking forward to receiving your application online. Please submit your CV or resume (w/o picture and w/o cover letter, reference letters and diplomas are optional)