Senior SQE: NPI & Production Quality Leader

deka; Richmond (NH); On-site; USD 110,000 - 150,000; Full time

Job summary

deka is seeking a Senior Supplier Quality Engineer to lead supplier quality activities across NPI and sustaining manufacturing. You will ensure supplier compliance with 21 CFR, ISO 13485, and drive qualification, development, and performance management across suppliers.

You will partner with Design Authority, Engineering, Procurement, and QA to select suppliers, perform risk-based assessments, and manage audits. Travel up to 20% may be required.

Qualifications

• Bachelor’s degree or equivalent experience in a regulated industry.
• 3–5 years of experience in Supplier Quality or Quality Engineering 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.

Responsibilities

• 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, Engineering, Procurement, and QA.
• 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.
• Own supplier quality oversight for assigned NPI projects and production suppliers.
• Monitor supplier performance using quality metrics (SCARs, defects, delivery).
• Lead supplier corrective action activities (SCAR/CAPA) and ensure timely closure.
• Conduct supplier performance reviews and drive continuous improvement.
• Support containment, root cause analysis, and resolution of supplier-related quality issues.
• Perform risk-based supplier re-evaluations and periodic assessments.
• Ensure supplier compliance with ISO 13485 and regulatory requirements.
• Maintain and improve Approved Supplier List (ASL) classification and risk-based controls.
• Support audits involving supplier quality systems.
• Ensure supplier quality agreements are established and maintained.

Skills

Communication skills

Cross-functional collaboration

Root cause analysis

Data-driven decision-making

Problem-solving

Attention to detail

Travel flexibility

Education

Bachelor’s degree in Engineering, Life Sciences, or related technical field

Equivalent experience in regulated industry

Tools

CAPA systems

FMEA

Quality management systems

Job description

deka is seeking a Senior Supplier Quality Engineer to lead supplier quality activities across NPI and sustaining manufacturing. You will ensure supplier compliance with 21 CFR, ISO 13485, and drive qualification, development, and performance management across suppliers.

You will partner with Design Authority, Engineering, Procurement, and QA to select suppliers, perform risk-based assessments, and manage audits. Travel up to 20% may be required.