Quality Assurance Specialist

As a Quality Assurance Specialist at Empatica, you will be a key member of the Quality and Regulatory Department, supporting the maintenance of the Quality Management System as well as:

• Champion Quality culture and compliance within the different development teams, supporting them in the compliance effort
• Continually seeks to drive improvements in product and process quality.
• Provides the quality/independent review at defined design reviews, design plans, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing products.
• Support team in performing required Risk Management activities 
• Support Engineering manager with the activities related to change management and new product development. Support developers in creating design control documentation, making sure product requirements and regulatory requirements are aligned.
• Support Design transfer activities to ensure quality compliance of the manufacturing process.
• Interfaces with Regulatory Affairs, Clinical Science, Marketing, and product manager to translate their needs in actionable and regulatory compliant requirements. 
• Implement, maintain and update procedures that ensure that the design control process constantly meets Empatica’s and regulatory requirements.
• Support Regulatory affairs in drafting EU Technical Documentation and US 510(k)s and De No