Quality Assurance Specialist

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

h3Overview /h3pIn 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. /ph3Retribuzione / Benefits /h3ulliHealth Insurance /liliEmployee stock options /liliFlexible working hours /liliLearning and development budget /liliWellhub gym access /liliFree lunch every day /li /ulh3Responsabilità /h3ulliSupport maintenance and update of the Quality Management System /liliProvide quality reviews at design reviews, plans, risk management,



and verification/validation activities /liliAssist with risk management activities and change management for new development and existing products /liliHelp ensure design control documentation aligns product requirements with regulatory requirements /liliSupport design transfer activities to ensure manufacturing quality compliance /liliInterface with Regulatory Affairs, Clinical Science, Marketing and Product Management to translate needs into compliant requirements /liliDraft and maintain regulatory documentation and procedures to meet Empatica and regulatory standards /liliEnsure production activities comply with internal procedures and international standards /liliStay current on ISO/EN/FDA/MDR and related regulatory requirements and communicate implications to product teams /li /ulh3Requisiti fondamentali /h3ulli3+ years of experience in QA, DQE, or similar roles in medical device companies /liliKnowledge of ISO 13485, 14971 /liliKnowledge of IEC 60601, 62304 /liliKnowledge of MDR 2017/745 /liliStrong analytical and problem-solving skills /liliAutonomous with good organizational skills /liliNative English speaker or English-experienced (≥3 years) /lilianalytical thinking /liliproblem-solving /liliautonomy /liliISO 13485 /liliISO 14971 /liliIEC 60601 /li /ul #J-18808-Ljbffr

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