Senior Supplier Quality Engineer

About the Position

Senior Supplier Quality Engineer

Manchester, NH

Full Time

Quality

Experienced

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We are seeking a Senior Supplier Quality Engineer to lead supplier quality activities across New Product Introduction (NPI) and sustaining manufacturing operations in Manchester, NH.

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Responsibilities

As a Senior Supplier Quality Engineer, you will:

• Lead supplier qualification activities for NPI projects
• Perform risk-based supplier assessments aligned with product and process criticality
• Support supplier selection decisions in collaboration with Design Authority (customer), Engineering, Procurement, and Quality Assurance
• Conduct supplier audits (remote and onsite) for new and existing suppliers
• Review and approve supplier documentation including certifications, validations, and quality records
• Ensure supplier readiness for production launch, including capacity, quality systems, and process controls
• Participate in design transfer and process validation activities where supplier input is required

Sustaining Supplier Quality Management

• Own supplier quality oversight for assigned NPI projects and production suppliers
• Monitor supplier performance using quality metrics (e.g., SCARs, defects, delivery performance)
• Lead 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
• Perform risk-based supplier re-evaluations and periodic assessments

Supplier Quality System & Compliance

• Ensure supplier compliance with applicable regulatory and quality system requirements including ISO 13485
• Maintain and improve Approved Supplier List (ASL) classification and risk-based controls
• Support external and internal audits involving supplier quality systems
• Ensure supplier quality agreements are established and maintained
• Drive adherence to change notification and supplier control requirements

Cross-Functional Collaboration

• Partner with Design Authority (customer), Procurement, Manufacturing, 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

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Requirements

• 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.

Skills & Competencies

• Experience with contract manufacturing and global supply chains
• Ability to interpret mechanical drawings (CAD files)
• Familiarity with statistical tools, risk analysis (FMEA), and CAPA systems
• Experience in lean manufacturing or continuous improvement environments
• 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

Preferred Certifications

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

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We Offer

• Competitive salary
• Full-time employment
• On-site work location in Manchester, NH
• Opportunity to work in a dynamic and innovative environment

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About the Company

DEKA Research & Development is a leading company in the medical device industry, dedicated to developing innovative solutions that improve patient outcomes. Our team is committed to quality, innovation, and excellence in every aspect of our work.

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