Graduate Engineer

With a high degree of autonomy performs quality work of a broad nature to achieve successful outcomes of departmental and company objectives.
The Quality Engineer will contribute to ensure that production and process control activities are conducted in compliance with the company quality system and the international regulations governing medical device manufacturing and distribution.
He/she evaluates situation of non-conforming products, collect and analyse data to propose product disposition and CAPA's to address quality issues.
With respect to Nonconforming product handling, He/She: Collect and critically analyze data and take disposition decision on nonconforming products identified in production
Generate the evaluation of the risk posed by the observed NC on products already distributed (HHA) to determine if Stop Shipment and/or FSCA are indicated.
Own CAPA process and trend data to identify opportunities for CAPA
Notify suppliers of any non-conformance related to purchased material and evaluate corrective actions consistency versus the internal production process.
He/She gives support to the batch record review for subassemblies/ semifinished products when needed
With respect to the Design Control & Production and Process control, He/She:
Establishes product quality control plans
Reviews process validation planning, protocols and reports
Perform preliminary review of the change impact assessment to confirm that quality requirements are met
Identify opportunities of quality improvements in the production area and lead improvement plan
Good knowledge of English (written and spoken);
Depth knowledge of Microsoft Office suite;
1-3 years of experience in medical device or pharmaceutical companies in QA departments.
Degree in Technical and Scientific disciplines (Physics, Chemistry, Engineering and Biology).
Travel Requirements