Sr. Supplier Quality Engineer

Job Purpose

A Senior Supplier Quality Engineer (SQE) is responsible for ensuring that external suppliers provide high-quality materials and components that meet rigorous technical and regulatory standards. This senior-level role involves leading complex audits, driving strategic supplier development, and acting as a technical liaison between the company and its supply base.

Principal Accountabilities

Supplier Auditing and Qualification:

• Lead on-site process and quality system audits to assess and evaluate supplier capabilities and ensure compliance with contract and regulatory requirements.
• Qualify new suppliers in accordance with Lighteum Medical’s supplier qualification procedures, validation, and requirements.
• Maintain and manage the Approved Supplier List (ASL), ensuring supplier classifications, qualifications documentation, and ongoing compliance records are accurate and current.
• Evaluate supplier quality systems and manufacturing processes to ensure the capability to consistently meet product specifications, regulatory standards, and customer requirements.

Documentation & Material Certification

• Review and verify required supplier documentation, including Material Test Reports (MTRs), Certificates of Conformance (CoC), Certificates of Analysis (CofA), and outside process certifications to ensure compliance with quality and regulatory requirements.
• Ensure supplier requirements are aligned with applicable customer requirements as defined in quality agreements and contractual specifications.
• Develop, implement, and continuously improve incoming inspection methods, procedures, and controls to support product quality and internal and regulatory compliance

Issue Resolution and Improvement:

• Lead structured problem-solving efforts related to critical supplier non-conformances, including root cause investigations and verifications of the effectiveness of corrective actions and preventive actions (CAPA/SCAR).
• Partner with suppliers to identify and implement opportunities for quality, process, and performance improvements to reduce defects and improve quality.
• Lead continuous improvement initiatives related to incoming quality performance, supplier defect reduction, and process capability improvement
• Collaborate with Engineering and Procurement to review specifications, GD&T, and technical drawings to ensure suppliers can consistently meet design and manufacturing requirements.

Suppliers’ Performance Management

• Monitor supplier performance using scorecards and Key Performance Indicators (KPIs) such as Defect Parts Per Million (DPPM), On-Time Delivery (OTD), and responsiveness to corrective actions
• Analyze supplier performance trends and lead suppliers' improvement initiatives to improve quality, delivery performance, and overall supplier reliability. performance metrics.

• Bachelor’s degree in Quality Engineering, Engineering, or related field.
• Minimum of 5+ years of experience in Quality within a highly regulated industry, medical device preferred.
• Willingness to travel frequently to supplier sites and business locations, including internationally, approximately 30%–70%.
• Demonstrated experience applying ISO 9001 and ISO 13485 requirements within a regulated manufacturing or medical device environment.
• ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent quality certification.
• Six Sigma certification.

Lighteum Medical is an Equal Opportunity Employer and encourages applications from qualified candidates regardless of sex, race, disability, age, sexual orientation, marital status, religion, belief, or any status protected by federal, state, or local law. If you require a reasonable accommodation to apply or participate in the interview process, please contact careers@lighteum.com.