Sr. Supplier Quality Engineer

Medical Device Components LLC•San Diego, CA

2d•$115,000 - $120,000

About The Position

At Lighteum Medical, we pride ourselves on being more than just a place of work. We are a vibrant, innovative team committed to making a difference in the world of medical device components by enhancing the lives of patients worldwide by delivering innovative, high-quality medical components to the MedTech industry. Be a part of a team dedicated to playing a role in creating solutions that make a real impact. Your work will contribute to improving lives. We offer a comprehensive benefits package designed to support our associates’ well-being. Our health and wellness benefits feature comprehensive medical, dental, and vision insurance. To promote financial security, we also provide a 401(k) plan with a generous company contribution and match, flexible spending accounts, and life and disability insurance. Our paid time off policy is generous, including PTO, sick leave, and paid holidays. Sr. Supplier Quality Engineer Salary Range: $115,000-$120,000 base + bonus 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.

Requirements

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.

Responsibilities

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.