Job Overview:
Responsible for Quality Risk Management activities for combination products by assisting with risk assessments, technical documentation, compliance reviews, and CAPA initiatives. Collaborate with cross-functional teams to ensure product quality, regulatory compliance, and continuous improvement throughout the product lifecycle.
Summary of Responsibilities:
These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties as individual contributor globally.
- Support the team in implementing risk management processes, procedures, and documentation required for the Quality Risk Management program. Focus will be on combination products used in surgical procedures; therefore, an understanding of surgical procedures would be beneficial.
- Assist in providing quality support for recent combination product development activities and lifecycle management.
- Prepare and contribute to technical reports in compliance with cGMP requirements.




- Collaborate with stakeholders and business partners to identify improvement opportunities and support the achievement of project goals and objectives. (This role may require participation in calls/meetings during US business hours.)
- Contribute to data-driven risk assessments, including risk identification, analysis, and evaluation, and support the development of risk mitigation and CAPA plans.
- Perform assigned activities in accordance with Standard Operating Procedures (SOPs).
- Support the coordination and maintenance of documents within the document management system.
- Assist in ensuring compliance with procedures and customer requirements.
- Help identify potential issues, support troubleshooting activities, assist in resolving documentation-related challenges, and coordinate issue resolution in a timely manner.
- Qualifications (Minimum Required):
- Bachelor’s in Engineering, life science or related Health science degree (or

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