Quality Assurance Specialist
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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.
Retribuzione / Benefits
Health Insurance
Employee stock options
Flexible working hours
Learning and development budget
Wellhub gym access
Free lunch every day
Responsabilità
Support maintenance and update of the Quality Management System
Provide quality reviews at design reviews, plans, risk management, and verification/validation activities
Assist with risk management activities and change management for new development and existing products개`,
Help ensure design control documentation aligns product requirements with regulatory requirements
Support design transfer activities to ensure manufacturing quality compliance
Interface with Regulatory Affairs, Clinical Science, Marketing and Product Management to translate needs into compliant requirements
Draft and maintain regulatory documentation and procedures to meet Empatica and regulatory standards
Ensure production activities comply with internal procedures and international standards
Stay current on ISO/EN/FDA/MDR and related regulatory requirements and communicate implications to product teams
Requisiti fondamentali
3+ years of experience in QA, DQE, or similar roles in medical device companies
Knowledge of ISO 13485, 14971
Knowledge of IEC 60601, 62304
Knowledge of MDR 2017/745
Strong analytical and problem-solving skills
Autonomous with good organizational skills
Native English speaker or English-experienced (≥3 years)
analytical thinking
problem-solving
autonomy
ISO 13485
ISO 14971
IEC 60601
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