Quality Assurance Assitant

Epygon Italie Srl (Gruppo Affluent Medical), company committed in biomededical field specialized in development and production of Class III Implantable Medical Devices, is lookng for a resource to be included, on a temporary basis (maternity leave replacement) as quality assurance assitant.

Main reponsibilities are:

- partecipate in the development of the quality management system and more specifically in the conformity of the products in accordance with applicable standards and quality requirements (NCs, CAPA, rework, batch records controls)
- partecipate to the supplier qualification and evaluation; in charge of the "Supplier approved list" update; suppliers audit
- responsible for batch tecords acceptance (DHR) and ensures that the manufactured product complies with estabilished requirements as defined in the Quality System (before the final release of sterile devices for clinical investigations by Regulatory department)
- all other activities as support to Quality Manager

Skills required:

- Experience in medtech or quality regulated environment
- Knowledge of regulatory requirements associated with Medical Devices (ISO 13485 for QMS; ISO 14971 for Risk Assessment; ISO19011 for Audit Practices) and MDR
- Analytical and reporting skills
- Fluency in Italian language and intermediate English language skills

Contratto di lavoro: Tempo determinato
Durata contratto: 12 mesi

Benefit:

- Mensa aziendale

Orario:

- Dal lunedì al venerdì
- Orario flessibile

Sede di lavoro: Ibrido/da remoto (10010 Colleretto Giacosa, TO)

Data di inizio prevista: 03/04/2023