Strategic Supplier Quality Lead for NPI & Compliance

Merrimack Manufacturing; Manchester, Northern (NH, KY); Hybrid; USD 110,000 - 140,000; Full time

Job summary

Merrimack Manufacturing, a medical device manufacturer in the Manchester Millyard, seeks a Senior Supplier Quality Engineer to lead supplier quality across NPI and sustaining operations. You will drive supplier qualification, development, and performance management to ensure quality, regulatory, and supply chain goals are met.

The Sr. SQE serves as a key technical liaison among the design authority, Merrimack Manufacturing, and suppliers, focusing on onboarding new suppliers, process validation

Qualifications

• 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.

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
• Ensure supplier quality agreements are established and maintained
• Drive adherence to change notification and supplier control requirements
• 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

Skills

Supplier quality leadership

Contract manufacturing

Global supply chains

Regulatory knowledge

Data-driven decision making

Cross-functional collaboration

Travel up to 20%

Education

Bachelor’s degree in Engineering or Life Sciences

Tools

CAD drawings

FMEA

CAPA systems

Job description

Merrimack Manufacturing, a medical device manufacturer in the Manchester Millyard, seeks a Senior Supplier Quality Engineer to lead supplier quality across NPI and sustaining operations. You will drive supplier qualification, development, and performance management to ensure quality, regulatory, and supply chain goals are met.

The Sr. SQE serves as a key technical liaison among the design authority, Merrimack Manufacturing, and suppliers, focusing on onboarding new suppliers, process validation