Senior Quality Assurance Specialist

This is an exciting opportunity to join a global provider of diagnostic informatics solutions as a Product Quality Assurance Specialist. As a key member of the product development team, you will play a critical role in ensuring the quality and safety of our products.

The successful candidate will be responsible for leading the quality assurance process for product development and lifecycle management. This will involve working closely with cross-functional teams to ensure smooth product launches and efficient on-market delivery and support.

You will also be responsible for conducting and documenting product and enterprise risk assessments that could impact or impede the safety, security, and functionality of our products or services.

Your expertise will be required to provide guidance for the improvement of business processes, products, software systems, training, and reporting of metrics and trends in accordance with internal and external regulations, policies, and procedures.

You will investigate and document actions to address complaints including notifications to customers and regulatory authorities.

In addition, you will be responsible for generating and updating Device History Files, designing inputs (user needs, product requirements), product specifications, and risk traceability matrix.

As a leader, you will guide global, cross-functional teams to align on requirements and specifications, troubleshoot issues, resolve issues, and implement corrections.

You will also project manage multiple timelines and products simultaneously, supporting the implementation, maintenance, and evolution of the Integrated Quality and Information Security Management systems under ISO 13485, 9001, 14971, and 27001.

You will establish policies and procedures to identify and address risks in our products, services, and departments.

You will review and assess risk management policies and protocols, making recommendations and implementing modifications and improvements.

You will conduct product and process risk assessments, monitor product and process KPIs, and communicate with regulatory authorities and customers when required.

You will draft and present risk reports and proposals to executive leadership and senior staff.

Key Responsibilities:

• Generate and update Device History Files: design inputs (user needs, product requirements), product specifications, risk traceability matrix.
• Lead global, cross-functional teams to align on requirements and specifications, troubleshooting issues, resolving issues, implementing corrections.
• Project manage multiple timelines and products simultaneously.
• Support the implementation, maintenance, and evolution of the Integrated Quality and Information Security Management systems under ISO 13485, 9001, 14971, and 27001.
• Establish policies and procedures to identify and address risks in our products, services, and departments.
• Review and assess risk management policies and protocols; make recommendations and implement modifications and improvements.
• Conduct product and process risk assessments.
• Monitor product and process KPIs.
• Communicate with regulatory authorities and customers when required.
• Draft and present risk reports and proposals to executive leadership and senior staff.

To succeed in this role, you will need:

• Risk Management Certification
• Bachelor's degree in Risk management, Engineering, Software Engineering, or Clinical discipline with risk management experience
• Minimum 5 years software development, medical device manufacturing, or clinical laboratory experience
• Knowledge and understanding of data protection and privacy standards: GDPR, HIPAA

About Onboarding:

New employees will be required to attend / travel to the office on their first day of employment for onboarding activities, including identity verification, completion of necessary documentation, receiving IT equipment, introductions to key team members, and orientation to our policies and procedures.