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Supplier Quality Engineer

Merrimack Manufacturing

Manchester, NH

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JOB DETAILS
JOB TYPE
Full-time
SKILLS
American Society for Quality (ASQ), Biology, CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), Certified Internal Auditor (CIA), Certified Quality Engineer (CQE), Change Control, Code of Federal Regulations, Communication Skills, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Detail Oriented, Documentation, Documentation Review, Engineering, External Audit, ISO (International Organization for Standardization), Internal Audit, Maintain Compliance, Manufacturing, Manufacturing Operations, Manufacturing Systems, Medical Equipment, Multitasking, Onboarding, Performance Analysis, Performance Management, Performance Reviews, Process Improvement, Process Validation, Product/Service Launch, Purchasing/Procurement, Quality Engineering, Quality Metrics, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Regulatory Requirements, Risk, Risk Management, Root Cause Analysis, Software Testing, Surveillance, Systems Analysis, Time Management, Vendor/Supplier Evaluation, Vendor/Supplier Quality Management, Vendor/Supplier Selection, Willing to Travel
LOCATION
Manchester, NH
POSTED
11 days ago
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 Supplier Quality Engineer (SQE) supports supplier quality activities across both New Product Introduction (NPI) and sustaining manufacturing operations within a regulated medical device environment. This role ensures supplier compliance to applicable requirements, including 21 CFR Part 820 and ISO 13485, and contributes to supplier qualification, development, monitoring, and performance management activities.

The SQE serves as a key interface between Engineering, Procurement, Quality, and the supplier base, supporting the assurance that suppliers consistently meet defined quality, regulatory, and performance expectations. This role supports supplier qualification activities for NPI programs, including onboarding of new suppliers, documentation review, and participation in process validation and design transfer activities. The SQE also supports sustaining supplier quality activities for production materials and services, including monitoring supplier performance and supporting resolution of supplier-related quality issues.

Key Responsibilities
Supplier Qualification & NPI Support
  • Support supplier qualification activities for New Product Introduction (NPI) projects
  • Conduct supplier assessments in accordance with established risk-based procedures
  • Support supplier selection activities in collaboration with Engineering, Procurement, and Quality
  • Participate in supplier audits (remote and onsite) as part of qualification and surveillance activities
  • Review supplier documentation including certifications, quality records, and validation evidence
  • Support supplier readiness activities for production launch, including process and quality system evaluations
  • Participate in design transfer and process validation activities involving suppliers
Sustaining Supplier Quality Management
  • Support supplier quality oversight for assigned NPI projects and production suppliers
  • Monitor supplier performance using quality metrics (e.g., SCARs, defects, delivery performance)
  • Support 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. 
  • 1-3 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
  • Understanding of quality systems and regulatory expectations (21 CFR Part 820, ISO 13485)
  • Exposure to supplier quality, manufacturing, or inspection processes preferred
  • Experience supporting NPI, manufacturing, or engineering projects a plus
Skills & Competencies
  • Good analytical and problem-solving skills
  • Ability to work effectively in cross-functional teams
  • Strong communication and documentation skills
  • Ability interpret mechanical drawings (CAD files)
  • Attention to detail and commitment to quality
  • Ability to manage multiple tasks in a dynamic environment
  • Basic understanding of manufacturing and quality systems concepts
  • Familiarity with CAPA, nonconformance, or inspection processes is a plus
  • Willingness to travel both domestically and internationally to suppliers as needed, estimated to be 10-20% travel
Preferred Certifications
  • ISO 13485 Internal Auditor certification (or willingness to obtain).
  • ASQ certifications (CQE, CQA, or similar) are a plus.

 

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Merrimack Manufacturing

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