Senior Supplier Quality & Development Engineer

Jobtailor; Reno (NV); On-site; USD 85,000 - 120,000; Full time

Job summary

Jobtailor in Reno, NV is seeking a skilled Supplier Quality professional to manage supplier qualification, audits, and ongoing performance.

You will collaborate with Quality, Materials, Engineering, Production, and suppliers to ensure regulatory compliance (FDA QMSR/ISO 13485) and robust supply chains.

Applicants should bring 3–7 years in supplier quality, a degree in a related engineering field, and strong analytical and communication abilities.

Qualifications

• 3–7 years of experience in supplier quality, supplier development, manufacturing engineering, or a closely related field.
• Bachelor’s degree in Manufacturing, Mechanical, Industrial, Biomedical Engineering, or a closely related discipline required.
• Direct experience working with external suppliers on quality and technical matters.
• Working knowledge of FDA Quality Management System Regulation (QMSR) (21 CFR Part 820) and/or ISO 13485 required.
• Proficient in ECO/change management systems, document control, data analysis, and Microsoft Office Suite.
• Able to read and interpret engineering drawings and GD&T required.
• Strong understanding of manufacturing processes, materials, machining, molding, assembly, process controls, and supplier manufacturing technologies in medical devices.
• Ability to evaluate supplier capabilities, processes, equipment against engineering and quality requirements.
• Knowledge of SPC, Cp/Cpk, sampling plans, trend analysis, and root cause methodologies (5 Whys, Fishbone, 8D).
• Experience with supplier audits, qualification, risk management, and supply continuity.
• ERP or supplier management systems (D365, SAP) familiarity; experience with supplier qualification/audit applications preferred.

Responsibilities

• Evaluate, select, qualify, and requalify suppliers based on capability, quality systems, manufacturing processes, capacity, and regulatory compliance
• Conduct supplier audits and assessments and support onboarding, qualification, design transfer, tooling transfers, and first article inspections
• Drive capability improvements through performance analysis, process optimization, capability studies, and structured improvement plans
• Implement supplier quality requirements, inspection criteria, material certifications, and traceability requirements
• Monitor supplier performance and risks related to process quality, delivery, capacity, and business continuity
• Resolve supply disruptions, shortages, delivery issues, and supplier-related production process challenges
• Manage supplier lifecycle risks, end-of-life components, replacement qualification, and supply continuity planning
• Lead or support supplier nonconformance investigations and corrective action implementation and verification
• Support Supplier Corrective Action Request activities and effectiveness verification
• Evaluate supplier, engineering, and specification changes for qualification, change control, and regulatory compliance
• Provide supplier qualification, audit, quality, technical, and performance documentation for regulatory and product lifecycle activities
• Manage assigned projects and collaborate with Quality, Materials, Engineering, Production, and supplier organizations

Job description

Jobtailor in Reno, NV is seeking a skilled Supplier Quality professional to manage supplier qualification, audits, and ongoing performance.

You will collaborate with Quality, Materials, Engineering, Production, and suppliers to ensure regulatory compliance (FDA QMSR/ISO 13485) and robust supply chains.

Applicants should bring 3–7 years in supplier quality, a degree in a related engineering field, and strong analytical and communication abilities.