Quality Assurance Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8my7x0

Overview 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.Per candidarsi, è sufficiente leggere la seguente descrizione del lavoro e assicurarsi di allegare i documenti pertinenti.Retribuzione / BenefitsHealth InsuranceEmployee stock optionsFlexibleworking hoursLearning and development budgetWellhub gym accessFree lunch every dayResponsabilitàSupport maintenance and update of the Quality Management SystemProvide quality reviews at design reviews, plans, risk management,



and verification/validation activitiesAssist with risk management activities and change management for new development and existing productsHelp ensure design control documentation aligns product requirements with regulatory requirementsSupport design transfer activities to ensure manufacturing quality complianceInterface with Regulatory Affairs, Clinical Science, Marketing and Product Management to translate needs into compliant requirementsDraft and maintain regulatory documentation and procedures to meet Empatica and regulatory standardsEnsure production activities comply with internal procedures and international standardsStay current on ISO/EN/FDA/MDR and related regulatory requirements and communicate implications to product teams xysqume Requisiti fondamentali3+ years of experience in QA, DQE, or similar roles in medical device companiesKnowledge of ISO 13485, 14971Knowledge of IEC 60601, 62304Knowledge of MDR 2017/745Strong analytical and problem-solving skillsAutonomous with good organizational skillsNative English speaker or English-experienced (≥3 years)analytical thinkingproblem-solvingautonomyISO 13485ISO 14971IEC 60601#J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8my7x0