We offer an interesting opportunity to join our Quality Engineering team, based in Bussolengo (VR) as 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 closely with the Design & Development Area promoting specific activities like Risk Management process, design verification, design validation, and final release and modification process. The Product Assurance Manager is responsible for ensuring, with the support of their team, the efficacy and effectiveness of the main activities described above.
The Manager will coordinate a team of 6 people.
What will your contribution be? Coordinate the team to cooperate and support the internal departments during the Product Development Process to permit the release (CE Mark, FDA approval) for: Support and manage the team to coordinate the Risk Management activities during the Product Development Process, product modification, and post-marketing surveillance. Support and manage the team to conduct (promote, coordinate, and finalize), in cooperation with R&D, Marketing, Medical Science, and Clinical Affairs, the design validation of new products. Support and manage the 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 the 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 the 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 the R&D area. Manage, in cooperation with the team, the activities required by post-market surveillance, including Field Safety Corrective Actions and trend analysis. Cooperate and contribute in a team with other departments (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 the department and MDR project team. What are we looking for? 2-3 years in a 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? Methodical thinking Excellent organizational skills Technical knowledge of the medical devices and Company manufacturing processes Project management Problem solving Skill in autonomy, orderliness, attention to detail, and deadlines Analytical approach to regulatory issues Able to work in a team and autonomously What will you find? Friendly, warm, and innovative atmosphere Healthy, inspiring, inclusive work environment Training and development opportunities Smart working model (two days per week) Competitive reward packages Annual bonus Social and company events Wellbeing initiatives (welfare - yoga classes) Canteen Benefits (Pension Fund - Health Insurance) What we offer?
This is a full-time job.
The contract is permanent.
Salary package range: 65,000 - 70,000 euro.
Do you want to join us? Are you ready to make a difference? We look forward to your application. Please send it to ******.
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