Quality Engineering Manager - Bussolengo, Italia - Orthofix

Orthofix

Azienda verificata

Bussolengo, Italia

2 settimane fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

We offer an interesting opportunity to join our Quality Engineering team, based in Bussolengo (VR) a
Quality Engineering Manager, reporting to the Quality Director Europe.

Quality Engineering is the liaison between Quality Assurance Area, Design & Development Area and Regulatory Affairs Area during the Design & Development phase of products.

It must guarantee that Design & Development activities are conducted in compliance with internal procedures and in conformity with standards, directives and laws applicable to the Organization.

It works strictly in contact with Design & Development Area promoting specific activities like Risk Management process, design verification, design validation and final release and modification process.

Product Assurance Manager is responsible to guarantee, with the support of its team, the efficacy and the effectiveness of the main activities described above.

The Manager will coordinate a team of 6 people.

What will your contribution be?

Coordinate its team to cooperate and support the internal departments during the Product Development Process to permit the release (CE Mark, FDA approval) for:

new products (standard products, small series, custom products)

product modifications.

Support and manage its team to coordinate the Risk Management activities during the Product Development Process, product modification and postmarketing surveillance.
Support and manage its team to conduct (promote, coordinate and finalize), in cooperation with R&D, Marketing, Medical Science and Clinical Affairs, the design validation about new products.
Support and manage its team to prepare and maintain the Technical File of new products or modified products and cooperate with Regulatory Affairs Area to prepare the 510K.
Support its team to prepare and maintain STED master file for regulatory purposes.
Support all the regulatory pre

- and post-market activities related to technical aspects.

Support and manage its team and R&D area to formalize:
development plan;

- documentation to formalize the "gates";
- risk analysis during the product development phase;
- design verification phase;

Implement and update internal procedures relevant to the above mentioned activities
Cooperate with Quality Assurance during the internal audit in R&D area
Manage, in cooperation with its team, the activities required by post market surveillance, includes Field Safety Corrective Actions and trend analysis
Cooperate and contribute in team with other department (R&D, Clinical, MarCom) to develop the Instructions For Use for the new products or modified products
Support in the preparation and verification of product technical & marketing sheets
Support and guarantee the implementation of European Medical Device Regulation EU 2017/745 in cooperation with its department and MDR project team

What are we looking for?

2-3 years in similar position preferably in a Medical Device Company
Fluency in English; other languages will be appreciated.
Good knowledge of Microsoft Office
Willing to travel 20/30% of your time, based on business needs.
Knowledge of relevant regulations (European MDD, FDA Guidances, ISO 13485, ISO 14971, RDC 59/2000 etc)

What soft skills will you improve?