Quality Assurance Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8mljou

Overview
In this role you contribute to maintaining Empatica's Quality Management System and champion a culture of quality across development teams. You'll support design control, risk management, and regulatory alignment for new and existing products, ensuring compliance with ISO, IEC, and MDR requirements. You will liaise with Regulatory Affairs, Clinical Science, Marketing, and product management to translate needs into compliant requirements. This position offers exposure to global regulatory submissions and a chance to impact product quality and process improvements in a fast-growing, international environment.
Retribuzione / Benefits
Salary range: 37,******,000 gross per year
Employee stock options
Health Insurance
Wellhub membership for fitness and nutrition
Mental health and wellness platforms
Flexible working hours
Responsabilità
Support design control documentation and ensure product and regulatory requirements are aligned
Provide quality reviews at design reviews, risk management, design verification/validation plans and reports




Assist with risk management activities and change management related to product development
Support regulatory submissions (EU Technical Documentation, US 510(k)s, De Novo) and regulatory compliance activities
Coordinate with Regulatory Affairs, Clinical Science, Marketing, and product management to translate needs into compliant requirements
Maintain and update procedures to ensure ongoing compliance of design controls with internal and regulatory standards
Support design transfer activities to ensure manufacturing process quality compliance
Ensure production activities comply with internal procedures and international standards
Requisiti fondamentali
BS or MS in Biomedical Engineering
??3??????????????????/Design Quality Engineer/Quality Engineer?
??ISO *****, *****???
??IEC *****, *****???
??MDR ********
????????????
????,????????????
????????3?????????
???
??????
????/???
ISO *****
ISO *****
IEC *****

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8mljou