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Senior Supplier Quality Engineer

Connexion Systems + Engineering

Manchester, NH, NH

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JOB DETAILS
SKILLS
American Society for Quality (ASQ), Auditing, 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, Contract Manufacturing, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Documentation, External Audit, Failure Mode and Effects Analysis (FMEA), ISO (International Organization for Standardization), Internal Audit, Leadership, Lean Manufacturing, Maintain Compliance, Manufacturing, Manufacturing Operations, Manufacturing/Industrial Processes, Medical Equipment, Onboarding, Performance Analysis, Performance Management, Performance Reviews, Problem Solving Skills, Process Control Engineering, Process Improvement, Process Validation, Product/Service Launch, Purchasing/Procurement, Quality Assurance, Quality Engineering, Quality Management, Quality Metrics, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Regulatory Requirements, Risk, Risk Analysis, Risk Management, Root Cause Analysis, Sales Qualification, Software Testing, Team Player, Time Management, Vendor/Supplier Evaluation, Vendor/Supplier Management, Vendor/Supplier Quality Management, Vendor/Supplier Selection, Willing to Travel
LOCATION
Manchester, NH, NH
POSTED
14 days ago
Senior Supplier Quality Engineer (Sr. SQE)


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 Company, manufacturing partner 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.

How you will make an impact as a Senior Supplier Quality Engineer:
  • 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

Skills you will need to be successful in this role:
  • 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
  • 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

About the Company

C

Connexion Systems + Engineering

Connexion is an award-winning professional staffing firm that strives to be the unrivaled staffing solution for job seekers by expertly connecting talent with opportunity.  Over the last 20 years Connexion has built the most admired team of staffing experts in the industry.  We give back, change lives and offer unconditional support to the candidates we represent.

Put Connexion's 20 years of experience to work for you! Our professionals have unrivaled relationships and contacts with the hiring managers, human resources team and decision makers at the most desirable companies to work for.

Don't let your resume get lost in an inbox, Connexion's recruiting team will advocate on your behalf to get you the job you want

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1999
WEBSITE
https://www.csetalent.com/

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