01 ago - Italia
MicroPort CardioFlow
Within the Quality Assurance team based in Saluggia, as Quality Engineer, you will support the development, manufacturing, release and post market surveillance activities associated with MicroPort CF products manufactured and released by the Saluggia plant. You will also ensure the maintenance of quality KPI, provide prompt support to Operations and enhance system efficiency to guarantee the achievement of the business goals, provide technical guidance to all peers on best practices and regulatory requirements. Si assicuri di inviare la sua candidatura con tutte le informazioni richieste, come indicato nella panoramica del lavoro riportata di seguito.
Your missions will be as follows
Responsibilities of this position include, but are not limited to, the following:
- Manage autonomously non conformities related to product and processes
- Develop, review and approve quality system procedures
- Complete and/or support in root cause investigation and corrective actions (CAPA)
- Actively participates to internal/external Audits
- Analysis of trends
- Lead or participate in projects (e.g. cost reduction and compliance) providing clear directions to other departments of product Quality and design testing requirements
- Lead or participate in the creation and maintenance of device Risk Management at all stages of the design process and review final technical responses and/or failure investigation reports.
- Maintain up-to-date knowledge of technology development for relevant projects and relative applicable standards.
- Collaborate, review, approve the development of new test methods as appropriate for evaluations of product characteristics.
- Collaborate, review, approve the Validation of the test methods to ensure they are accurate, reliable and repeatable.
- Collaborate, review, approve the process validation strategy for new products to minimize product risks.
- Manage all the Quality related activities to give desired project outcomes in terms of quality and meeting de
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