Dialife is a fast-growing company in the field of hemodialysis. We offer a comprehensive portfolio of medical devices for hemodialysis treatment, including dialysis machines, dialyzers, blood lines, fistula needles, bicarbonate cartridges, concentrate solutions, disinfectants and endotoxin filters. Our clientele is primarily composed of international distributors, located in approximately 30 countries.
Based in Ticino (Switzerland), Dialife offers its medical devices under its own CE marking and in conformity with its ISO 13485-certified quality management system. Accordingly, Dialife is the legal, certified manufacturer of all the devices it offers, which are in turn assembled at multiple production sites located in different countries.
In this context, the Quality Assurance Manager of Dialife is responsible for all quality assurance activities and regulatory affairs of the company, among which:
- Ensure compliance with applicable medical device directives and ISO 13485 standards across the technical files, quality management system, procedures and documents of the company, through regular monitoring, planning and updating as required.
- Assure conformity and traceability of each produced medical device throughout the supply chain, from initial lot numbering of the device, to reviewing production and quality control documentation, attesting conformity, releasing the device on the market and keeping record of its destination.
- Investigate and resolve any issue and/or non-conformity influencing product quality and/or the quality management system, in coordination with other managers involved.
- Evaluate, approve and monitor suppliers from a QA/RA perspective.
- Document each audit (internal and external) to attest conformity with the requested specifications and implemented procedures of Dialife.
- Prepare documentation and procedures as necessary to integrate new devices and suppliers in the portfolio and quality management system of Dialife.
- Support new product registrations and certification requirements to offer Dialife devices in new countries.
- Interact regularly with production partners, suppliers, regulatory authorities, colleagues and management to implement the above responsibilities, in an international environment.
The ideal candidate will have a relevant academic background with at least 5 years of experience in quality assurance management of medical devices, as well as a thorough understanding of the regulations and requirements in the context of European medical device directives and ISO 13485 certification. Knowledge of US FDA regulations is not required but would be a plus. The candidate should have a strong command of English, in addition to Italian. Other languages welcome.
Dialife is open to considering a variety of profiles, provided they have relevant experience and knowledge with the involved regulations, and the ability to take on the responsibility. Dialife also places great value on positive attitudes and entrepreneurial spirits, in addition to qualifications.
In case of interest, please send your application in English to: [email protected]