Connexion · 7 hours ago
Supplier Quality Engineer
Waltham, MA
Full-time
Hybrid
Senior Level
$40/hr - $64/hr
7+ years expConnexion is seeking a Supplier Quality Engineer to join their growing Supplier Quality team. This role focuses on ensuring the quality, compliance, and performance of the client’s global supplier base, involving supplier audits, capability testing, and continuous improvement initiatives.
Graphic DesignTranslation Service
Responsibilities
Support supplier development programs by identifying capability gaps and enabling continuous improvement plans with key and critical suppliers. Partner with Sourcing to align on strategic supplier performance
Supplier Change Notifications (SCNs): Evaluate and manage Supplier Change Notifications, ensuring that all changes are documented, reviewed, and analyzed for impact on quality and compliance. Coordinate cross-functional review teams to assess the potential risks of supplier changes
Supplier Qualifications: Conduct technical evaluations and qualifications for new and existing suppliers. This includes reviewing supplier manufacturing processes, capabilities, and compliance with the client’s engineering and quality requirements
Supplier Corrective Action Requests (SCARs): Initiate and manage SCARs to address non-conformances identified during audits or routine quality checks. Work with suppliers to implement effective corrective and preventive actions, conducting follow-up audits to verify the effectiveness of actions taken. Standardize and drive accountability in SCAR closure timelines and root cause quality. Implement risk-based SCAR prioritization to ensure critical issues receive senior-level supplier attention. Collaborate with Procurement to reinforce supplier performance expectations
Non-Conformance Material Reports (NCMRs): Manage the NCMR process, ensuring timely identification, documentation, and resolution of non-conforming materials from suppliers. Collaborate with suppliers to investigate root causes and implement corrective actions to prevent reoccurrence. Lead efforts to reduce repeat NCMRs through trend analysis, supplier feedback loops, and CAPA integration. Coordinate with internal teams to ensure timely disposition of materials and closeout of NCMRs. Own the escalation process for high-risk or recurring NCMRs with Procurement and Supplier Quality leadership
Supplier Performance and Scorecards: Develop and maintain supplier scorecards to monitor performance on key metrics, including quality, delivery, cost, and service. Collaborate with suppliers to identify areas of improvement based on performance trends
Approved Supplier List (ASL) Maintenance: Ensure that the client’s Approved Supplier List (ASL) is regularly updated to reflect current supplier status. Work cross-functionally to qualify and requalify suppliers based on quality performance and audit results
Conduct Supplier Audits: Plan and perform on-site and remote audits of suppliers to evaluate their quality management systems, production processes, and adherence to engineering specifications. Provide detailed audit reports, including risk assessments and recommendations for improvement
Conduct Risk Assessments: Perform supplier risk assessments to evaluate the likelihood and impact of potential risks to quality, regulatory compliance, and supply chain reliability. Develop and monitor risk mitigation strategies, especially for high-risk suppliers
Continuous Improvement Initiatives: Partner with suppliers to drive continuous improvement in quality, cost, and delivery. Use root cause analysis, statistical tools, and engineering methods to help suppliers optimize their processes and products
Product and Process Validation: Assist in the validation of supplier processes and products, including first article inspections, process capability studies, and engineering evaluations. Ensure that all supplier-provided materials and components meet the client’s technical and quality specifications
Compliance with Regulatory Standards: Ensure supplier adherence to industry regulations (FDA, GMP, etc.) and maintain up-to-date knowledge of applicable regulatory and quality standards. Collaborate with the internal compliance team to align supplier practices with the client's regulatory obligations
Act as a liaison between Quality, Procurement, Engineering, and Regulatory functions to ensure cohesive supplier strategies and decisions
Qualification
Required
Bachelor's degree in engineering, Quality, or related technical field
7+ years of experience in supplier quality engineering, manufacturing engineering, or quality assurance
Supplier QMS & Process auditing experience (ISO 9001)
Strong problem-solving skills, including root cause analysis and corrective action methodologies
Proficiency in conducting risk assessments and quality audits
Experience with eQMS systems or digital audit tools
Familiarity with regulatory standards (FDA, GMP, etc.)
Excellent communication, negotiation, and interpersonal skills
Willingness to travel for supplier audits and evaluations
Company
Connexion
Connexion creates and localizes multilingual websites and graphically design and produce offline and online communication.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase