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Skills
- American Society for Quality (ASQ)unmatched
- Biologyunmatched
- Certified Internal Auditor (CIA)unmatched
- Certified Quality Engineer (CQE)unmatched
- Change Controlunmatched
- Code of Federal Regulationsunmatched
- Continuous Improvementunmatched
- Corrective Actionunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Cross-Functionalunmatched
- Documentationunmatched
- Engineeringunmatched
- External Auditunmatched
- ISO (International Organization for Standardization)unmatched
- Internal Auditunmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Manufacturing Operationsunmatched
- Medical Equipmentunmatched
- Performance Analysisunmatched
- Performance Managementunmatched
- Performance Reviewsunmatched
- Process Improvementunmatched
- Process Validationunmatched
- Product/Service Launchunmatched
- Purchasing/Procurementunmatched
- Quality Engineeringunmatched
- Quality Metricsunmatched
- Quality System Requirements (QSR)unmatched
- Regulationsunmatched
- Regulatory Complianceunmatched
- Regulatory Requirementsunmatched
- Riskunmatched
- Risk Managementunmatched
- Root Cause Analysisunmatched
- Software Testingunmatched
- Surveillanceunmatched
- Systems Analysisunmatched
- Time Managementunmatched
- Vendor/Supplier Evaluationunmatched
- Vendor/Supplier Quality Managementunmatched
- Vendor/Supplier Selectionunmatched
Description
Supplier Quality Engineer
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.
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
- Bachelors 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
- ISO 13485 Internal Auditor certification (or willingness to obtain).
- ASQ certifications (CQE, CQA, or similar) are a plus.
Numbers & Facts
| Location | Bedford, NH |
| Industry | Staffing/Employment Agencies |
| Company Size | 500 to 999 employees |
| Year Founded | 1999 |
| Website | https://www.csetalent.com/ |
About Company
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.
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