Senior Supplier Quality Engineer: NPI & Compliance Leader

Connexion Systems & Engineering Inc.; Bedford (NH); On-site; USD 90,000 - 120,000; Full time

Job summary

Connexion Systems & Engineering Inc. seeks a Senior Supplier Quality Engineer to lead supplier quality activities for New Product Introduction and sustaining manufacturing programs in New Hampshire.

You will drive supplier qualification, development, and performance management, ensuring regulatory and quality compliance, including ISO 13485. The role requires robust supplier audits, risk assessment, and collaboration with design authority, engineering, procurement, and QA teams to ensure on-time

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related technical field (or equivalent regulated-industry experience).
• 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 preferred.
• Strong understanding of manufacturing processes, validation, and quality systems.

Responsibilities

• Lead supplier qualification activities for New Product Introduction (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.
• 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.

Skills

Contract manufacturing

Global supply chains

CAD interpretation

FMEA

CAPA systems

Lean manufacturing

Education

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

Tools

CAD software

Statistical tools

CAPA software

Job description

Connexion Systems & Engineering Inc. seeks a Senior Supplier Quality Engineer to lead supplier quality activities for New Product Introduction and sustaining manufacturing programs in New Hampshire.

You will drive supplier qualification, development, and performance management, ensuring regulatory and quality compliance, including ISO 13485. The role requires robust supplier audits, risk assessment, and collaboration with design authority, engineering, procurement, and QA teams to ensure on-time