Quality Assurance Specialist
2 giorni fa
Milano, Lombardia, Italia
Empatica
Tempo pieno
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Overview In this role you contribute to maintaining Empatica's Quality Management System and champion a culture of quality across development teams. You'll support design control, risk management, and regulatory alignment for new and existing products, ensuring compliance with ISO, IEC, and MDR requirements. You will liaise with Regulatory Affairs, Clinical Science, Marketing, and product management to translate needs into compliant requirements. This position offers exposure to global regulatory submissions and a chance to impact product quality and process improvements in a fast-growing, international environment. Retribuzione / Benefits
* Salary range: 37,000–45,000 gross per year
* Employee stock options
* Health Insurance
* Wellhub membership for fitness and nutrition
* Mental health and wellness platforms
* Flexible
working hours
Responsabilità
* Support design control documentation and ensure product and regulatory requirements are aligned
* Provide quality reviews at design reviews, risk management, design verification/validation plans and reports
* Assist with risk management activities and change management related to product development
* Support regulatory submissions (EU Technical Documentation, US 510(k)s, De Novo) and regulatory compliance activities
* Coordinate with Regulatory Affairs, Clinical Science, Marketing, and product management to translate needs into compliant requirements
* Maintain and update procedures to ensure ongoing compliance of design controls with internal and regulatory standards
* Support design transfer activities to ensure manufacturing process quality compliance
* Ensure production activities comply with internal procedures and international standards Requisiti fondamentali
* BS or MS in Biomedical Engineering
* 至少3年在医疗设备公司担任质量保证相关职务/Design Quality Engineer/Quality Engineer等
* 熟悉ISO 13485, 14971等标准
* 熟悉IEC 60601, 62304等标准
* 熟悉MDR 2017/745
* 优秀的分析与问题解决能力
* 自主性强,具备良好的组织与管理能力
* 英语为母语或过去3年内在英语工作经验
* 分析力
* 问题解决能力
* 自我驱动/自治性
* ISO 13485
* ISO 14971
* IEC 60601
* Salary range: 37,000–45,000 gross per year
* Employee stock options
* Health Insurance
* Wellhub membership for fitness and nutrition
* Mental health and wellness platforms
* Flexible
working hours
Responsabilità
* Support design control documentation and ensure product and regulatory requirements are aligned
* Provide quality reviews at design reviews, risk management, design verification/validation plans and reports
* Assist with risk management activities and change management related to product development
* Support regulatory submissions (EU Technical Documentation, US 510(k)s, De Novo) and regulatory compliance activities
* Coordinate with Regulatory Affairs, Clinical Science, Marketing, and product management to translate needs into compliant requirements
* Maintain and update procedures to ensure ongoing compliance of design controls with internal and regulatory standards
* Support design transfer activities to ensure manufacturing process quality compliance
* Ensure production activities comply with internal procedures and international standards Requisiti fondamentali
* BS or MS in Biomedical Engineering
* 至少3年在医疗设备公司担任质量保证相关职务/Design Quality Engineer/Quality Engineer等
* 熟悉ISO 13485, 14971等标准
* 熟悉IEC 60601, 62304等标准
* 熟悉MDR 2017/745
* 优秀的分析与问题解决能力
* 自主性强,具备良好的组织与管理能力
* 英语为母语或过去3年内在英语工作经验
* 分析力
* 问题解决能力
* 自我驱动/自治性
* ISO 13485
* ISO 14971
* IEC 60601