Senior Supplier Quality Engineer

Merrimack Manufacturing; Manchester (NH); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

Merrimack Manufacturing in Manchester, NH is seeking a Senior Supplier Quality Engineer to lead supplier quality across NPI and sustaining operations. You will ensure supplier capability to meet quality, regulatory, and performance expectations, partnering with design, engineering, procurement and QA.

Responsibilities include leading supplier qualification, conducting audits, monitoring performance with metrics, driving CAPA and risk-based improvements, and ensuring ISO 13485 compliance across

Formación

• Bachelor’s degree in Engineering, Life Sciences, or related technical field.
• 3–5 years of experience in Supplier Quality in medical devices 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.

Responsabilidades

• Lead supplier qualification activities for NPI projects.
• Conduct supplier audits (remote and onsite) and review approvals of certifications, validations and quality records.
• Monitor supplier performance using quality metrics (SCARs, defects, delivery).
• Lead supplier corrective action (SCAR/CAPA) and ensure timely closure.
• Support containment, root cause analysis and resolution of supplier-related quality issues.
• Perform risk-based supplier re-evaluations and periodic assessments.

Conocimientos

Supplier quality

ISO 13485

Audits

NPI support

Risk management

Cross-functional

Global supply

Educación

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

Herramientas

CAD

CAPA systems

Descripción del empleo

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.

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.

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