Senior Supplier Quality Engineer

Manchester, NH

Full Time

Quality

Experienced

Company Overview
Merrimack Manufacturing is a medical device manufacturer located in the Manchester Millyard. We are a growing manufacturing company that will play a crucial part in bringing innovative and life changing products to life.

Position Summary
The Senior Supplier Quality Engineer (Sr. SQE) is responsible for leading supplier quality activities across both New Product Introduction (NPI) and sustaining manufacturing operations. This role ensures supplier compliance to applicable requirements, including 21CFR, ISO 13485, and drives robust supplier qualification, development, and performance management processes.

The Sr. SQE serves as a key technical and quality liaison between the design authority (customer), Merrimack Manufacturing and its supplier base, with primary responsibility for ensuring suppliers are capable of consistently meeting quality, regulatory, and performance expectations. This role will heavily support supplier qualification activities for NPI programs, including process validation support, and onboarding of new suppliers, while also managing sustaining supplier quality performance for production materials and services.

Key Responsibilities
Supplier Qualification & NPI Support

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

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

Qualifications
Education & Experience

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 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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