Supplier Quality Engineer
About The Position
The Supplier Quality Engineer ensures suppliers consistently meet the organization's quality, regulatory, and operational requirements. Reporting to the Senior Quality Assurance Engineer, the role partners with suppliers and Procurement, Manufacturing, Engineering, and Operations teams to drive supplier performance, manage supplier-related quality issues, and ensure the quality and reliability of purchased materials, components, and services. The position supports supplier qualification, monitoring, auditing, risk management, and continuous improvement to minimize quality risks throughout the supply chain. The role also supports sourcing parts, components, and associated processes, maintains supplier quality records and documentation, and contributes to internal and external audits and regulatory inspections involving supplier controls. Travel to supplier sites is required as needed; stated travel is 10%.
Requirements
- Bachelor's degree in Engineering, Manufacturing Engineering, or a related technical discipline.
- 2 to 5 years of experience in Supplier Quality, Quality Engineering, Manufacturing Quality, or a related function.
- Knowledge of Quality Management Systems, including ISO 13485, ISO 9001, FDA Quality System Regulations, or equivalent standards.
- Experience conducting supplier audits and supplier assessments.
- Understanding of supplier qualification, supplier monitoring, and supplier development processes.
- Strong knowledge of CAPA, nonconformance management, root cause analysis, and risk management methodologies.
- Familiarity with statistical analysis and quality tools.
- Ability to interpret technical drawings, specifications, and manufacturing documentation.
- Strong written and verbal communication skills.
- Excellent problem-solving and project management abilities.
- Willingness to travel to supplier sites as required.
Nice To Haves
- Experience in a regulated industry such as medical devices or a related field.
Responsibilities
- Manage supplier quality activities for assigned suppliers and commodities.
- Monitor supplier performance using established quality metrics and key performance indicators; review data, identify trends, and communicate potential risks to management.
- Support supplier qualification, onboarding, and requalification, and ensure suppliers meet applicable quality, regulatory, and contractual requirements.
- Plan, conduct, and support qualification, surveillance, and for-cause supplier audits and assessments.
- Assess supplier quality systems, manufacturing processes, and compliance with applicable standards and regulations.
- Document audit findings, track corrective actions through closure, evaluate supplier responses, and verify the effectiveness of implemented actions.
- Lead investigations of supplier quality issues involving nonconforming materials, components, and services; coordinate containment and timely resolution.
- Facilitate root cause analysis using methods such as 5-Why, Fishbone Analysis, and FMEA.
- Review and approve supplier corrective action reports, monitor implementation, and verify the effectiveness of supplier corrective and preventive actions.
- Partner with Procurement and Supply Chain on supplier selection and development; collaborate with Manufacturing, Engineering, and Quality on supplier-related production issues.
- Participate in product transfers, process changes, and new product introduction activities involving suppliers.
- Provide quality input for supplier change notifications and risk assessments.
- Identify and assess supplier-related risks affecting product quality, delivery, or compliance.
- Support supplier development and continuous improvement initiatives to improve quality performance, reduce defects, and strengthen supply chain robustness.
- Use statistical analysis and quality tools to support data-based decision-making.
- Ensure supplier quality activities comply with applicable regulations, industry standards, and company quality system requirements.
- Maintain supplier quality records, audit reports, and approved supplier documentation.
- Support internal audits, customer audits, and regulatory inspections involving supplier controls.
- Assist in developing and revising supplier quality procedures, standards, and work instructions.
- Participate in sourcing parts, components, and associated processes.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
