Quality Assurance Specialist

Empatica; Varese; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Health Insurance

Employee stock options

Flexible

Wellhub gym access

Free lunch every day

Job summary

Empatica is seeking a QA/Regulatory professional to uphold quality culture across development teams. You will support design control, risk management, and verification/validation to ensure products meet regulatory and company standards.

You will liaise with Regulatory, Clinical Science, Marketing and Product Management to translate needs into compliant requirements, enabling safe, high-quality devices and ongoing process improvement.

Qualifications

• 3+ years of QA, DQE, or similar roles in medical device companies.
• Knowledge of ISO 13485 and ISO 14971.
• Knowledge of IEC 60601 and IEC 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 and problem-solving highlighted in role.
• ISO 13485 and ISO 14971 familiarity.

Responsibilities

• 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 products.
• 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.

Skills

Analytical thinking

Problem-solving

Autonomy

English proficiency

ISO 13485

ISO 14971

IEC 60601

IEC 62304

MDR 2017/745

Job description

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 products
• 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