Quality Engineer

Spectrum Killian Dental Lab Alliance provided pay range

This range is provided by Spectrum Killian Dental Lab Alliance. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$80,000.00/yr - $/yr

About Us:

Spectrum Killian Dental Lab Alliance (SKDLA) is a nationally recognized leader in restorative dentistry, passionate about helping people smile with confidence. We partner with dental professionals across the country to deliver world‑class restorations, advanced dental equipment, and trusted services that make a difference for patients every day.

At SKDLA, we combine craftsmanship, cutting‑edge technology, and a deep commitment to quality to create beautiful, lasting results. More than just a dental lab, we are driven by the belief that every restoration represents a person’s confidence, comfort, and well‑being — and that’s a responsibility we take to heart.

Our operations are centered around two advanced Centers of Excellence located in Orange County and Los Angeles. This collaborative environment allows our skilled technicians to innovate, mentor one another, and consistently deliver outstanding results.

Overview:

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.

• Investigate customer complaints and product dissatisfaction cases to identify root causes related to design, process, handling, or usage.
• Conduct deep‑drive 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…