We are a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998, with more than 1500 employees, 45+ nationalities and 30 subsidiaries all over the world (Europe, Asia and the Americas). Joining PQE Group means being a part of a multicultural and challenging company, with many local and international projects and colleagues from all over the world.
Due to a constant growth, PQE Group is looking for a Junior R&D – Medical Devices Consultant who will support our clients based in Mirandola, Italy.
Joining PQE will give you the opportunity to acquire the following professional competencies:
- Drafting of the design documentation: design requirements, design plans, design inputs-outputs traceability matrix, verification and validation protocols and reports, design review reports, DHF;
- Participation in design change activities and management of design change documentation;
- Participation in planning and conducting design verification and validation activities;
- Participation in planning and conducting test method validation activities;
- Participation in design transfer activities;
- Manage (i.e. promote, coordinate and document) the Risk Management activities during the Product Development Process, in relation to product modifications and during post-marketing surveillance;
- Prepare and maintain Summary Technical Documentation (STED) for regulatory purposes;
- Cooperate with internal departments during the Product Development Process to permit regulatory release (CE Mark, FDA approval etc.);
- Prepare and maintain the Technical File documentation (e.g. Device Master File) for new products or modified products and cooperate with Regulatory Affairs Area to prepare regulatory submissions (e.g. 510K pre-market notifications);
- Assists regulatory department with FDA, CE, and other regulatory submissions;
- Assists in implementing and maintaining a quality system that is compliant with ISO 13485 and with quality system regulation requirements.
Requirements:
- Technical Degree in Biomedical Engineering
- Full availability to Travel up to 75%
- English language fluency in speaking and writing (at least B2/C1)
- Availability for body rental activities (from 1 to 3 years of on-site permanence by our clients’ sites)
Location: Mirandola, Italy
Our collaborators are engaged, developed, challenged and well-rewarded for performance. We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.