The Supplier Quality Engineer is responsible for planning, coordinating, and reporting on all supplier quality activities to ensure materials, components, and services meet contractual, regulatory, and company requirements.
The role covers raw materials, packaging materials, GMP service providers, contract manufacturers, laboratories, and sub-tier suppliers. The successful candidate will ensure supplier performance, compliance, and continuous improvement across the supply chain.
Key Responsibilities
Supplier Quality Management
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Lead and manage supplier quality activities to ensure compliance with purchase orders, contracts, and applicable standards.
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Maintain oversight of supplier approvals and ensure certifications remain current.
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Review, challenge, and approve new supplier capability requests and accreditations.
Nonconformance & Corrective Action
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Control and manage supplier nonconforming materials.
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Conduct root cause analysis and ensure effective corrective and preventive actions are implemented.
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Monitor and verify the effectiveness of corrective measures against defined reliability and compliance standards.
Quality Systems & Compliance
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Develop, apply, and maintain quality evaluation and control systems for materials and product processing.
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Prepare, maintain, and review procurement quality assurance procedures.
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Ensure documentation complies with customer and/or government requirements.
Auditing & Supplier Oversight
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Perform source inspections and validation activities.
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Conduct audits of third-party manufacturers, special processes, and sub-tier suppliers.
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Participate in vendor selection and due diligence processes.
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Maintain effective feedback loops with suppliers and internal stakeholders.
Cross-Functional Collaboration
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Work closely with engineering, manufacturing, and quality teams to ensure requirements are clearly defined and communicated to suppliers.
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Translate technical and quality requirements into measurable supplier standards.
