Supplier Quality Engineer

Job Description

Job Description

The Supplier Quality Engineer is responsible for leading supplier quality activities during design transfer and process/product validation. This role ensures supplier compliance to applicable requirements, including 21CFR, ISO 13485, and drives supplier development and performance management processes. The SQE serves as a key technical and quality liaison between the DEKA design team and manufacturing partners with primary responsibility for ensuring suppliers are capable of consistently meeting quality, regulatory, and performance expectations. This role will heavily support process and tool validation support, while also managing sustaining supplier quality performance for production materials and services.

• Review and approve supplier documentation including certifications, validations, and quality records
• Ensure supplier readiness for production launch, including quality systems, and process controls
• Participate in design transfer and process/tool validation activities such as IQ/OQ/PQ, MSA and Statistical analysis

• Supplier development and continuous improvement to ensure effective design transfer
• Monitor supplier performance using quality metrics (e.g., SCARs, defects, delivery performance)
• Lead/Support supplier corrective action activities (SCAR/CAPA) and ensure timely closure
• Conduct supplier performance reviews and drive continuous improvement initiatives
• Support containment, root cause analysis, and resolution of supplier-related quality issues

• Ensure supplier compliance with applicable regulatory and quality system requirements including ISO 13485
• Support external and internal audits involving supplier quality systems
• Drive adherence to change notification and supplier control requirements

• Partner with Contract Manufacturing, Procurement, and Engineering
• Support material nonconformance investigations and disposition decisions
• Provide supplier risk input to project teams and change control processes
• Support supply continuity and risk mitigation strategies
• Writing Test Methods to support Validation

• Bachelor’s degree in Engineering, Life Sciences, or related technical field; or equivalent experience in regulated industry may be considered in lieu of degree.  
• 3–5 years of experience in Supplier Quality, Quality Engineering, or related role in medical device or regulated industry
• Strong knowledge of ISO 13485 and medical device regulatory requirements
• Experience with supplier audits, qualification, and risk-based supplier management
• Experience supporting NPI or design transfer activities strongly preferred
• Strong understanding of manufacturing processes, validation, and quality systems.

• Experience with medical device manufacturing and global supply chains
• Ability to interpret mechanical drawings
• Familiarity with statistical tools (Minitab), risk analysis (FMEA), and CAPA systems
• Experience in process and tool validation
• Strong technical judgment and problem-solving skills
• Ability to lead supplier interactions and drive accountability
• Excellent communication and cross-functional collaboration skills
• Strong root cause analysis and data-driven decision-making capability
• Ability to manage multiple priorities in a fast-paced NPI and production environment
• High attention to detail and regulatory compliance mindset
• Willingness to travel both domestically and internationally to suppliers as needed, estimated to be 20% travel

• ISO 13485 Internal Auditor certification preferred.
• ASQ certifications (Supplier Quality Professional, Green Belt, CQE, CQA, or similar) are a plus.

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