Quality Assurance Specialist Milano

Quality Assurance Specialist
Milano
Lombardia, Milano

She/he is responsible for control and batch releases of final products, and all the quality tasks linked to the such as timely and correct management of deviations, non-conformities, CAPA, complaints and related investigations.

Under the supervision of the Quality Assurance Manager, Partners closely with Production team, Manufacturing Engineering, Supplier Quality assurance and Project Managers to drive continuous improvement in Quality, and Delivery on commercial products and to ensure new products are implemented with key process controls and product checks in place using business improvement methodologies.

- Ensure the production batches compliance.

She/he will be responsible for control the batch record documentation and execute the batch release on the ERP according to the shipment planning.

Supervise the request of additional analysis for sterilization and bioburden control and keep update the record of results.

- Manage non-conformity and deviations through the investigation process and documentation analysis, assessing the seriousness and the associated risks.

She/he will drive also the root cause investigation involving the necessary functions and departments.

- Manage the implementation of the corrective and preventive actions as output of deviations, and ensure that corrective measures put in place are effective through evidence collection (such as documentation, training execution, etc)

- Participate to New Product Development Programs Particularly Design Transfers / and Change Management activities.

- Manage and supervise the delivery of reusable garments for clean room.

Keep contact with the supplier for managing deviations in case of repair, substitution, etc.

- Communicate and cooperate with other departments as required to solve issues

- Ensure that the processes required for the Quality Management System are established, implemented and maintained up to date.

Support in streamline processes and update QMS documentation and procedure accordingly

Manage the rework activities: track the reworks, participate in the risk analysis definition, define actions needed and supervise the effective closures.

Biomedical Company|Great growth opportunity

- Positive, accountable and with a spirit of initiative and able to work autonomously.

The resource needs to work independently

- Excellent organizational skills, analytical abilities, and ability to multi-task

- Bachelor's degree (engineering, a technical field or equivalent)

- 1/3 years of experience in working in Quality Assurance and production related area.

- Experience working in a regulated industry (Medical Device, Pharma, Aerospace, etc)

- Knowledge of Quality System principle such as ISO 9001, ISO13485, CFR820, ISO 14001.

- Experience with performing Root Cause Analysis

- Experience in preparing data and charts for Management

- Excellent computer skills including Word, Excel, Power Point and Visio

- Experience in working in contact with Operations area and with knowledge of manual and automatic assembly is preferred

- Knowledge of contamination controlled area and cleanroom validation is preferred

- Occasional domestic travel required

- Fluent in Italian and English both written and spoken.

Our client is a biomedical company with more than 50 years of experience in the production of medical devices.

For our client, biomedical company specialized in the production of medical devices, we are currently looking for a Quality Assurance specialist