Quality Engineer (QMS)

This role supports the execution of post-market quality processes by managing CAPA documentation, risk file alignment, and recall scoping activities. The position ensures accurate analysis of quality signals, facilitates CAPA investigations, and maintains compliance with regulatory requirements.

Requirements

• Ensure that all CAPAs, Safety Alerts (SAs), Risk Assessments (RAs), Health Risk Assessments (HRAs), and Health Hazard Evaluations (HHEs) are aligned with the applicable risk files and determinations.
• Facilitate updates to risk documentation as needed to reflect current understanding and mitigations.
• Gather and organize data to identify affected units and customers.
• Assist in defining the scope of recalls and field actions, ensuring accuracy and completeness of impact analysis.
• Contribute to the development of presentations and documentation for internal Field Action Committee reviews and external regulatory communications.
• Ensure materials are clear, data-driven, and aligned with quality and regulatory standards.
• Drive timely development and implementation of field action solutions by analyzing complex issues, coordinating with collaborators, and ensuring solutions are robust, validated, and aligned with regulatory requirements.
• Ensure quality documentation is properly maintained and audit ready.
• Support audit preparation, execution, and response activities for both internal and external inspections.
• Analyze quality data to support investigations, identify trends, and generate reports.
• Track and manage the execution of field action solutions.
• Analyze Quality Data Trends (15% of Time) and prepare documentation for the facilitation weekly and daily management meetings with collaborators to review metrics and drive accountability.

Benefits

• Paid Time Off
• Health Insurance
• Retirement Plan
• 401k Matching
• Life Insurance
• Disability Insurance