Quality Assurance Specialist

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

pOverview In this role you help uphold Empatica’s quality culture and regulatory compliance across development teams. You will support design control, risk management, and verification/validation activities to ensure products meet regulatory and company standards. You’ll liaise with Regulatory, Clinical Science, Marketing, and Product Management to translate needs into compliant requirements and support submissions. Your work enables safe, high-quality devices while driving continuous improvement in processes and products. /p h3Retribuzione / Benefits /h3 ul liHealth Insurance /li liEmployee stock options /li liFlexible /li /ul h3working hours /h3 ul liLearning and development budget /li liWellhub gym access /li liFree lunch every day /li /ul h3Responsabilità /h3 ul liSupport maintenance and update of the Quality Management System /li liProvide quality reviews at design reviews, plans, risk management,



and verification/validation activities /li liAssist with risk management activities and change management for new development and existing products /li liHelp ensure design control documentation aligns product requirements with regulatory requirements /li liSupport design transfer activities to ensure manufacturing quality compliance /li liInterface with Regulatory Affairs, Clinical Science, Marketing and Product Management to translate needs into compliant requirements /li liDraft and maintain regulatory documentation and procedures to meet Empatica and regulatory standards /li liEnsure production activities comply with internal procedures and international standards /li liStay current on ISO/EN/FDA/MDR and related regulatory requirements and communicate implications to product teams /li /ul h3Requisiti fondamentali /h3 ul li3+ years of experience in QA, DQE, or similar roles in medical device companies /li liKnowledge of ISO 13485, 14971 /li liKnowledge of IEC 60601, 62304 /li liKnowledge of MDR 2017/745 /li liStrong analytical and problem-solving skills /li liAutonomous with good organizational skills /li liNative English speaker or English-experienced (≥3 years) /li lianalytical thinking /li liproblem-solving /li liautonomy /li liISO 13485 /li liISO 14971 /li liIEC 60601 /li /ul #J-18808-Ljbffr

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