What are the responsibilities and job description for the Senior Supplier Quality Engineer position at Connexion Systems and Engineering, Inc.?
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) 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
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) 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
- 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 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
- 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.
- 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
- ISO 13485 Internal Auditor certification preferred.
- ASQ certifications (CQE, CQA, or similar) are a plus.