Supplier Quality Engineer

JOB SUMMARY

The Supplier Quality Engineer is responsible for ensuring supplier compliance with purchasing controls, qualification standards, and continuous monitoring requirements. This role involves collaboration with internal teams and suppliers to uphold regulatory standards, drive quality improvements, and mitigate risks in the supply chain. In addition to compliance tasks, continuous improvement initiatives are a key focus, ensuring that processes evolve to enhance efficiency and effectiveness.

JOB RESPONSIBILITIES

• Purchasing Controls Compliance: Maintain and oversee purchasing controls compliance, ensuring proper documentation of supplier performance and continuous monitoring files.
• Supplier Qualification & Monitoring: Lead supplier qualification initiatives, assess ongoing performance, and ensure adherence to regulatory and company standards.
• Training & Education: Provide education and training to company personnel and suppliers on purchasing control applications to sustain long-term compliance.
• Product Development Support: Collaborate with engineering teams to guide supplier selection and documentation of requirements for new materials and components.
• Regulatory Alignment: Ensure selected suppliers meet regulatory requirements, possess recognized credentials, and demonstrate competency for intended purchasing needs.
• Supplier Performance & Corrective Actions: Manage and analyze supplier corrective action reports, monitor performance trends, and provide insights for site-level management reviews.
• Supplier Audits: Conduct remote and onsite supplier audits to verify compliance, identify risks, and drive continuous improvement.
• Continuous Improvement Initiatives: Engage in continuous improvement activities within the function and areas of responsibility. Beyond compliance, focus on enhancing processes, identifying opportunities for efficiency, and driving meaningful improvements.
• Pre-Market Activities Collaboration: Work closely with Product Development teams to support pre-market activities, ensuring supplier selection, qualification, and documentation align with regulatory and business requirements.

QUALIFICATIONS

• Bachelor’s degree in engineering, supply chain management, or a related field. Background in electronics/electrical engineering is preferred.
• Experience in supplier quality management, auditing, and regulatory compliance.
• Strong understanding of purchasing controls, supplier qualification processes, and corrective action management particularly with contract manufacturing.
• Excellent communication, problem-solving, and analytical skills.
• Ability to collaborate effectively with cross-functional teams and external suppliers.
• ISO 13485 Certified Lead Auditor or CQA required

SKILLS & ABILITIES

• Excellent skills in written and verbal communication, and ability to interact with all levels of the organization and suppliers
• Superior organizational abilities and the ability to maintain deadlines.
• Ability to take initiative
• Ability to build team relationships and interface in a multi-disciplinary environment
• Ability to translate technical requirements and specifications to external suppliers
• Working knowledge of software programs; Microsoft Word, PowerPoint, Excel, Project
• Position requires some travel, international and domestic (Up to 50%)