Senior Supplier Quality Engineer, Medical Devices & Manufacturing Quality
Overview
Own supplier quality strategy across a complex technical supply chain in Bedford MA and ensure product quality at scale. Partner with Engineering, Procurement, Operations and Manufacturing to integrate supplier quality requirements into NPI and alternate sourcing. Drive audits, corrective action, capability assessments and continuous improvement for Critical-to-Quality characteristics. Lead root cause analysis with structured methodologies and promote zero defect quality mindset. This role offers exposure to global suppliers and cross functional collaboration with a focus on manufacturing excellence.
What You'll Do10
- 1Build and execute a comprehensive supplier quality strategy aligned with business goals and operational objectives.
- 2Partner with Engineering, Procurement, Operations, and Manufacturing to integrate supplier quality requirements into NPI and critical initiatives.
- 3Drive the complete supplier lifecycle from initial assessment through qualification, ongoing performance monitoring, corrective action, and continuous improvement.
- 4Establish and maintain robust processes for supplier selection, qualification, assessment, and performance management.
- 5Conduct supplier audits, capability assessments, and performance evaluations at domestic and international locations; document findings and track corrective actions.
- 6Monitor supplier quality KPIs including defect rates, NCRs, customer complaints to identify trends and risks.
- 7Evaluate supplier manufacturing processes and assess CTQ process capability; partner to troubleshoot and implement corrective actions.
- 8Lead structured root cause analysis using 8D, 5-Why, Fishbone, and Kepner-Tregoe; train suppliers on quality expectations.
- 9Review FAI requirements and AQL sampling plans; apply SPC and Cp/Cpk to evaluate process performance.
- 10Communicate critical quality issues and improvement expectations to suppliers and internal stakeholders.
Requirements10
- 18+ years in Supplier Quality Engineering or related manufacturing quality discipline.
- 2Experience conducting supplier and internal quality audits.
- 3Working knowledge of ISO 9001, ISO 13485, IATF 16949 or similar QMS.
- 4Understanding of mechanical drawings, GD&T, and electromechanical schematics.
- 5Proficiency with 8D, 5-Why, Fishbone, and Kepner-Tregoe problem-solving methodologies.
- 6Knowledge of SPC and process capability analysis including Cp and Cpk.
- 7Familiarity with FAI requirements and AQL sampling methodologies.
- 8Ability to interpret CMM reports and assess CTQ characteristics in supplier processes.
- 9Strong analytical, communication, and stakeholder management skills.
- 10Proficiency with MS Office especially Excel, Word, PowerPoint.
Salary Insight
$120 - $140k per year
Location
Required Skills
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