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Salary: EUR 37,000 - 45,000 / annual
Empatica is seeking a Quality Assurance Specialist to join its Quality and Regulatory Department in Milan. This hybrid role is central to maintaining and advancing the company's Quality Management System for medical devices.
Key Responsibilities:
- Champion quality culture and compliance across development teams, supporting their regulatory efforts
- Drive continuous improvements in product and process quality
- Provide independent quality reviews at design reviews, design plans, risk management activities, and design verification/validation protocols for new projects and design/process changes
- Support risk management activities and engineering teams with change management and new product development
- Assist developers in creating design control documentation, ensuring alignment of product and regulatory requirements
- Support design transfer activities to maintain manufacturing quality compliance
- Interface with Regulatory Affairs, Clinical Science, Marketing, and product management to translate requirements into actionable, regulatory-compliant specifications
- Implement, maintain, and update procedures ensuring design control processes meet Empatica and regulatory standards
- Support Regulatory Affairs in drafting EU Technical Documentation and US 510(k) and De Novo submissions
- Ensure production activities comply with internal procedures and applicable international standards
- Stay current on ISO/EN/FDA/MDR and product development regulatory requirements, communicating updates to the Product Development group
Empatica is a fast-growing, international company of 120+ employees with offices in Milan and Boston, operating in an international environment where all work is conducted in English. The company emphasizes diversity (30+ nationalities, 50%+ women) and offers a collaborative, learning-focused culture.
Requirements:
- BS or MS in Biomedical Engineering
- Minimum 3 years of experience as a Quality Assurance Specialist, Design Quality Engineer, Quality Engineer, or similar role in a medical device design/manufacturing company
- Knowledge and experience with ISO standards (13485, 14971, etc.)
- Knowledge and experience with IEC standards (60601, 62304, etc.)
- Knowledge of MDR 2017/745
- Excellent analytical and problem-solving skills
- Autonomous, well-organized, with strong management skills
- Native English speaker or minimum 3 years of professional English work experience
