Quality and Regulatory Manager Surgery - Haag, Schweiz - medmix AG

Beschreibung

medmix is a global leader in high-precision delivery devices. We occupy leading positions in the healthcare, consumer, and industrial end-markets. Our customers benefit from our dedication to innovation and technological advancement that has resulted in over 900 active patents. Our 14 production sites worldwide, together with our highly motivated and experienced team of nearly 2'600 employees provide our customers with uncompromising quality, proximity, and agility. medmix is headquartered in Baar, Switzerland. Our shares are traded on the SIX Swiss Exchange (SIX: MEDX).

The Quality and Regulatory Manager is responsible for ensuring that the quality system requirements have been effectively established and effectively maintained in accordance with applicable standards (ISO and regulations and for reporting on the performance of the quality system to management with executive responsibility. He is in charge of the technical and strategic management of the Quality and Regulatory, of the proper cooperation with other sites, and he is the main point of contact with certification bodies, competent authorities and customers for all Quality and Regulatory matters.

• Leadership tasks: translate the Quality direction and guidance and goals from the top management into operating principles and tactics and lead and drive the teams to make things happen, working daily to remove roadblocks and bottlenecks and providing teams with technical expertise on Quality and Regulatory Compliance topics and reasonable solutions.
• Being an advocate of the safety/effectiveness/quality of the products and of the customer satisfactions, while being always business oriented.
• Lead the organization in the development, implementation and continuous improvement of a Quality Management System tailored to the business needs, risk of the devices, yet fully compliant with applicable standards and regulations
• With an hands-on approach tackle the daily quality issues and sort them out, while implementing a long-term strategy
• Responsible for all the site quality processes, such as: Quality control/acceptance activities, CAPA, complaints, internal audits, Design Control, Management Review.
• Ensure that complaints are properly and timely managed, and that corrective actions are implemented as needed.
• Front man during external audits
• Compile and sustain the Technical Documentation (DHF, DMR, DHR, Technical Files)
• Support customers for all the Quality and Regulatory topics related to the site products
• Participate to the medmix best practices sharing and possible QMS harmonization
• Completed technical degree
• Deep knowledge and working experience and expertise of ISO 13845 and RA topics (EU and US)
• At least 5 years of experience as Quality and Regulatory Manager (ISO in the medical device manufacturing environment (both as Supplier and as Legal Manufacturer).
• Highly beneficial previous experience with injection molding
• Fluent in English (mandatory), German (beneficial)
• Focus on solutions rather than obstacles
• Pragmatic and strongly proactive, results oriented profile
• Able to work in a fast paced environment
• Hybrid working model
• Opportunity for your development
• Great team and working atmosphere

medmix is an equal opportunity employer, committed to the strength of a diverse workforce.

93% of our employees would go above and beyond to deliver results – do you have the drive to succeed? Join us and boost your career, starting today