As a Quality Assurance Specialist at Empatica, you will be a key member of the Quality and Regulatory Department, supporting the maintenance of the Quality Management System as well as:
- Champion Quality culture and compliance within the different development teams, supporting them in the compliance effort
- Continually seeks to drive improvements in product and process quality.
- Provides the quality/independent review at defined design reviews, design plans, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing products.
- Support team in performing required Risk Management activities
- Support Engineering manager with the activities related to change management and new product development. Support developers in creating design control documentation, making sure product requirements and regulatory requirements are aligned.
- Support Design transfer activities to ensure quality compliance of the manufacturing process.
- Interfaces with Regulatory Affairs, Clinical Science, Marketing,



and product manager to translate their needs in actionable and regulatory compliant requirements.
- Implement, maintain and update procedures that ensure that the design control process constantly meets Empatica’s and regulatory requirements.
- Support Regulatory affairs in drafting EU Technical Documentation and US 510(k)s and De Novo submissions
- Ensure production activities are compliant with internal procedures and internationally applicable standards.
- Keeps up to date on all ISO/EN/FDA/MDR and other Product Development related regulatory requirements and relay this information to the Product Development group.

Requirements

The ideal candidate for this role:
- Has a genuine interest, passion and motivation for Empatica's mission.
- Has a strong academic background, BS or MS in Biomedical Engineering
- Has at least 3 years of experience as a Quality Assurance Specialist, Design Quality

📌 Quality Assurance Specialist (Milano)
🏢 Empatica
📍 Milano