Senior Supplier 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

• • Evaluate, select, qualify, and requalify suppliers based on technical capability, quality systems, manufacturing processes, capacity, and regulatory compliance
• • Conduct supplier audits and assessments and support supplier onboarding, qualification, design transfer, tooling transfers, and first article inspections
• • Drive supplier 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

Requirements

• 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 used in medical device manufacturing
• Ability to evaluate supplier technical capabilities, manufacturing processes, equipment, and process capability against engineering, quality, and business requirements
• Working knowledge of SPC, Cp/Cpk, sampling plans, trend analysis, and root cause analysis methodologies including 5 Whys, Fishbone, and 8D
• Ability to conduct supplier audits and assessments and evaluate supplier performance using quality, delivery, capacity, and risk-based metrics
• Working knowledge of supplier qualification, supplier development, supplier risk management, ASL management, business continuity planning, and supplier performance monitoring
• Working knowledge of QMSR, ISO 13485, supplier quality systems, process validation methodologies (IQ/OQ/PQ), material certifications, and traceability
• Ability to work independently with minimal supervision, manage multiple priorities, adapt to changing business needs, and elevate significant risks or issues
• Effective communication and cross-functional collaboration skills
• Drug and background screenings required
• Medical device, electronics, or other regulated manufacturing experience preferred
• Supplier qualification or audit application preferred
• Statistical analysis tools preferred
• Familiarity with ERP or supplier management systems such as D365 or SAP preferred
• Experience with supplier auditing, FAI, incoming inspection, process validation, or supplier quality improvement initiatives preferred

Core Competencies

Demonstrates expertise in supplier quality management, including supplier qualification, audits, and performance monitoring, while ensuring compliance with FDA QMSR and ISO 13485 standards. Proficient in data analysis, process optimization, and cross-functional collaboration to drive supplier capability improvements in regulated manufacturing environments.

Highest-signal resume keywords

• Supplier Quality Management
• FDA Quality Management System Regulation (QMSR)
• ISO 13485
• Supplier Audits and Assessments
• Data Analysis

ATS Optimization Keywords

Hard Skills

• Supplier Qualification
• Process Validation
• Root Cause Analysis
• Statistical Process Control (SPC)
• Engineering Drawings Interpretation
• Change Management Systems
• Performance Metrics Evaluation
• Manufacturing Processes Knowledge
• Material Certifications
• Traceability Requirements

Soft Skills

• Effective Communication
• Cross-Functional Collaboration
• Adaptability
• Problem-Solving

Industry Keywords

• Medical Device Manufacturing
• Supplier Development
• Supplier Risk Management
• Business Continuity Planning
• Regulatory Compliance

Tools & Technologies

• Microsoft Office Suite
• ECO/Change Management Systems
• ERP Systems (D365, SAP)
• Statistical Analysis Tools