What are the responsibilities and job description for the Senior Supplier Quality Engineer-Onsite position at Elyon International?
The Senior Supplier Quality Engineer – Integration is a critical leadership role responsible for ensuring supplier quality, compliance, and continuity during periods of change, including M&A, supplier transitions, product transfers, and external manufacturing integrations. This role serves as the single-threaded owner for supplier quality integration, partnering closely with Supply Chain, Operations, R&D, Regulatory, and external suppliers to stabilize, align, and optimize supplier performance.
Responsible for achieving a state of high-quality performance at our Supplier partners through the application and practice of Advanced Product Quality Planning ‘APQP’ , Supplier Qualification (Audit, Quality Agreement/Change Notice Agreement), and continuous monitoring the performance supplier to drive zero defect through Supplier Corrective Actions and notification. You will fill a high-profile, cross functional position and play an integral role enabling development and production flow of the company's IGTD’s critical supply base. You will work in close coordination with Product Engineering, Supply Chain and Production and Suppliers to execute effective, creative and smart supply chain strategies to achieve production goals.
Your role:
• Lead supplier quality due diligence activities during M&A, including risk assessments, compliance reviews, and continuity planning
• Support pre-close and post-close integration planning for critical suppliers and externally manufactured products
• Develop and execute supplier and product stabilization plans for high-risk or single-source suppliers
• Partner with Legal and Procurement on change-of-control considerations, quality agreements, and supplier onboarding
• Act as the primary SQE interface to Supply Chain, Operations, R&D, Regulatory, and Program Management during integration efforts
• Provide clear risk-based recommendations to leadership to support timely decision-making
• Drive alignment across functions on quality expectations, escalation paths, and governance cadence
• Establish and manage supplier quality scorecards and integration KPIs
• Track and report supplier risk, issue resolution, and integration progress to leadership
• Identify opportunities for supplier consolidation, capability improvement, and process harmonization
• Conducts thorough investigations of defects to determine if they are supplier-caused and implement corrections using the SCAR process.
• Proactively manage, monitor, and troubleshoot supplier-related issues for quality of components, sub-assemblies, and assemblies including monitoring trends and managing Supplier Improvement and Supplier Quality Performance Monitoring.
• Providing Quality oversight of product/process change requests from suppliers (SICRs: Supplier Initiated Chage Requests), ensuring appropriate regulatory review and adequate validation to support requested changes including following our APQP process and leading process validation, as necessary.
• Develop and oversee process validation plans, including equipment qualifications, with suppliers and lead continuous improvement projects based on process/product trends, customer complaints, industry standards and government regulations.
• Perform and lead Supplier Audits, Value Stream Mapping and process enhancement.
You're the right fit if:
• Bachelor Degree engineering (Master Degree is plus). 3 years of engineering experience (Manufacturing Engineer and/or Product Quality is plus).
• In-depth product manufacturing and quality experience in process validation and verification.
• ISO 13485 Lead Auditor certified is plus.
• Strong Manufacturing Engineering background to drive problem solving and E2E process improvement.
• Strong commodities knowledge in Extrusion, Stent, Sheet metal, machining and electronics are plus.
• Prefer 3 years of experience in Supplier Quality, Supplier Evaluation, Data Analysis, DFX Methodology, Process Validation, Continuous Improvement.
• Strong written, oral and interpersonal skills to be able to effectively interface interdepartmentally and complete assignments with accuracy and a high attention to detail.
Benefits:
Paid sick leave, Medical/Dental (optional), 401 (k) Retirement Plan (optional), Employer Paid Life Insurance, Employer Paid Short Term Disability, Optional Life Insurance.
ELYON International, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Salary : $60