A market leader for non-invasive technology are looking for a QARA Manager to be based at their growing site in Neuchatel. This is an opportunity to join an international fast-paced organisation. They are building out a brand-new division and undergoing huge transformation. On offer are unrivalled future development opportunities, an international working environment, and an attractive compensation package.
Responsibilities :
Development of the QMS as per Iso13485, 21 CFR 820, MDSAP
Deputise to the QMR and PRRC
Conduct internal audits and support on external audits
Perform root cause analyses and implement CAPAs
Preform Risk analyses according to ISO14971
Assist in the compilation of technical documentation for manufactured products
Assist in the registration and maintenance of product registration worldwide
Requirements :
Minimum 4 years in the medical device industry, 2 years of which has to be in quality management
Expert knowledge of ISO13485, MDSAP, ISO14971, MDD / MDR (2017 / 745)
Fluency in English
Please reach out for more details.
Interviews are starting ASAP.