Staff Quality Assurance Analyst

The Staff Quality Assurance Analyst plays a key role in supporting Quality Management System (QMS) enhancements, coordinating audits, managing customer complaints, and performing advanced data analysis to identify trends and drive continuous improvement.

Requirements

• Perform detailed investigations, root cause analysis, and determine reportability where applicable (e.g., MDR, vigilance reporting).
• Ensure timely closure of complaints and maintain accurate documentation in complaint management systems.
• Support Field Action processes by providing complaint data analysis and risk assessment inputs.
• Perform advanced statistical analysis on quality data (complaints, audit findings, CAPA metrics, PMS data).
• Prepare dashboards and reports for management review and regulatory submissions.
• Support implementation and improvement of QMS processes to ensure compliance with ISO 13485, FDA QSR, and local regulatory requirements.

Benefits

• Full and comprehensive benefits program
• Growth opportunities on a global scale
• Access to career development through in-house learning programs and/or qualified tuition reimbursement
• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve