Quality Engineer

The Quality Engineer is a key member of the Operational Excellence & Quality organization, responsible for ensuring that both external partners and internal processes deliver products that meet all performance, regulatory, and customer expectations.

This role blends Supplier Quality Engineering, customer experience analysis, and regulatory compliance, ensuring product reliability from initial supplier input through final customer use. The ideal candidate has hands-on experience managing regulated quality systems, auditing suppliers, and leading investigations to understand why a product failed to meet a patient’s or doctor’s expectations, translating those insights into measurable improvements.

• Develop, deploy, and maintain the Supplier Quality Management System (SQMS) to ensure consistent quality and compliance across contract manufacturers, material vendors, and design partners.
• Conduct supplier qualification and capability validation through process audits, first article inspections, and documentation reviews.
• Establish and manage monthly supplier scorecards to track quality, delivery, responsiveness, and corrective action performance.
• Lead supplier Root Cause and Corrective Action (RCCA) investigations and verify long-term effectiveness through data-driven monitoring.
• Partner with Procurement and Operations to evaluate supplier performance and support supplier development programs to strengthen process capability.
• Provide direct feedback and coaching to suppliers to help improve inspection techniques, process control, and documentation.
  
  Product Performance & Customer Experience

• Investigate customer complaints and product dissatisfaction cases to identify root causes related to design, process, handling, or usage.
• Conduct deep-dive analyses on why a patient or doctor determined a product did not meet expectations, leveraging inspection data, production records, and supplier feedback.
• Collaborate with Customer Service, R&D, and Operations to define containment actions, preventive measures, and systemic improvements.
• Translate field data and customer insights into actionable improvements for product design, manufacturing processes, and supplier performance.
• Participate in complaint reviews, CAPA boards, and post-market surveillance activities to ensure thorough documentation and feedback integration.

• Develop, implement, and maintain a Quality Management System (QMS) compliant with FDA, ISO 13485, or ISO 9001 standards.
• Actively participate in design reviews, design control activities, and certification processes to ensure compliance throughout regulatory submission and product lifecycle.
• Support Verification and Validation (V&V) planning, execution, and documentation, ensuring supplier and internal processes meet product specifications.
• Conduct internal and external audits and manage closure of findings through effective corrective actions.
• Create and Manage design history files for all regulated product releases
• Manage FURLS, GUDID database in alignment with Quality Management System
• Ensure employees named in Quality Management System are trained in accordance with job responsibilities
• Ensure supplier documentation, traceability, and record control meet all applicable regulatory and certification requirements.
• Collaborate with cross-functional teams to prepare for FDA inspections and third-party audits.

• Drive continuous improvements and demonstrate Quality Management System Effectiveness
• Analyze supplier and customer performance data to identify recurring trends and prioritize improvement efforts.
• Collaborate with Continuous Improvement and Process…