Quality Assurance Engineer

Evaluate quality data including investigating complaints, nonconformances, and CAPAs. Drive for root cause understanding and corrective action implementation to ensure product meets requirements.

Monitor and ensure timely closure of US and OUS complaint/feedback and work with cross- functional teams on any potential reportable events.

Assist with hosting external audits from partnerships and regulatory authorities.

Contribute to the timely closure of audit findings.

Perform or assist with audits of US suppliers and manage supplier documentation.

Maintain clinical trial documentation, as needed, within the organization in accordance with

regulatory standards.

Ensure quality and regulatory requirements are met for all product distributed by Biofourmis in

the US.

Review documents that are submitted and maintained in Biofourmis's document and product

lifecycle management system adhering to GDP requirements.

Contribute to the successful completion of design transfer plans and qualification activities.

Author or review key component engineering lifecycle deliverables throughout product

development, as defined by procedures.

Track timelines and facilitating the required project deliverables.

Work independently to determine and develop efficient solutions that are thorough,

practicable, and consistent with organizational objectives.

Demonstrate ability to document test data, analyze test results utilizing statistics, write clear

and concise lab reports, and make recommendations to evaluate product.

Improve and update US specific SOPs or WIs.