Spectrum Killian Dental Lab Alliance · 3 weeks ago
Quality Engineer
Santa Ana, CA
Full-time
Onsite
Mid Level
$80K/yr - $100K/yr
4+ years expSpectrum Killian Dental Lab Alliance (SKDLA) is a nationally recognized leader in restorative dentistry, passionate about helping people smile with confidence. The Quality Engineer is responsible for ensuring that both external partners and internal processes deliver products that meet all performance, regulatory, and customer expectations, focusing on supplier quality, product performance, and regulatory compliance.
Medical Device
Responsibilities
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-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 Engineering teams to incorporate lessons learned into internal processes and training programs
Support and occasionally facilitate kaizen events and structured problem-solving sessions focused on improving supplier reliability and product quality
Promote a culture of proactive problem-solving and ownership of quality across the extended value chain
Qualification
Required
Bachelor's degree in Engineering, Quality, or related technical discipline
4+ years of experience in Supplier Quality Engineering or external manufacturing quality roles in a regulated or precision manufacturing environment
Hands-on experience developing and maintaining Quality Management Systems (QMS) in FDA- or ISO-regulated environments
Demonstrated experience with FDA design reviews, design controls, and certification processes
Proven track record conducting supplier audits, capability assessments, and scorecard management
Skilled in Root Cause and Corrective Action (RCCA), 8D, and DMAIC methodologies
Strong analytical ability to interpret data, detect patterns, and communicate insights to both technical and executive audiences
Comfortable managing multiple supplier relationships across domestic and international regions
Excellent communication and relationship-building skills to influence internal teams and external partners
ASQ Certified Supplier Quality Professional (CSQP), Certified Quality Engineer (CQE), or equivalent certification a plus
Experience in medical device, dental, or life-science manufacturing a plus
Preferred
Knowledge of process validation, PPAP, and statistical process control (SPC)
Experience supporting FDA inspections or ISO audits
Benefits
Comprehensive medical, dental, and vision insurance plans
401K
Company
Spectrum Killian Dental Lab Alliance
Spectrum Killian Dental Lab Alliance (SKDLA) is a cooperative network of full-service dental laboratories that have come together to provide high-quality products, dental implant solutions, and world-class esthetics.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Edwin Fajardo
Founder
Company data provided by crunchbase