Quality R&D Specialist - Fixed Term (10020)
We are looking for a **Quality R&D Specialist (fixed term - 1 year**) to be inserted in our team of **Design Control for Drug Delivery Systems in Milan** (IT).
This person will be responsible for the activities in the product development projects assigned, ensuring design control compliance with the QMS and applicable standards, reviewing and approving all project deliverables in alignment with the leader above;
examinates design reviews, contributing to the next phase approval and supports regulatory registrations.
**Activities**:
- Executes the activities in order to ensure that products design development and transfer to Operations follow the design control process, acting as a team member of the product development projects and supporting the Design Team in technical decision.
- Reviews and approves the design control records, the design history file (DHF), risk management documentations and other relevant documents, acts as quality assurance representative expert, ensuring the documents completeness and accuracy, the adequateness of the personnel involved respect the fields of competence, the coherence of conclusions, in compliance with applicable standards, regulations and regulatory requirements.
**Qualifications
- Academic background in biomedical engineering (or similar fields)
- Experience in quality or R&D in medical devices or pharma company will be considered a plus
- Fluency in English and Italian, both written and spoken (you will work in international team)
- Analytical approach and precision
**About Us
We are a dynamic organization with great customers and a culture where people are valued and empowered to deliver amazing results.
We are also growing and looking to hire talented and passionate individuals to join our team!
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