Sr. Supplier Quality Engineer

Required Sr. Supplier Quality Engineer
The Senior Supplier Quality Engineer is responsible for ensuring that suppliers meet or exceed Stratasy's quality standards and performance expectations. This position involves managing supplier quality issues, leading audits, driving continuous improvement initiatives, and collaborating with cross-functional teams to support new product introductions. The Senior Supplier Quality Engineer will focus on maintaining strong supplier relationships, reducing defect rates, and ensuring that all supplied materials and components meet our standards.
What will you be doing:
Develop and maintain supplier quality requirements to align with our standards and regulatory requirements (e.g., ISO 9001:2015)
Review supplier quality performance through KPIs, supplier scorecards, and other metrics. Identify trends and work with suppliers to address performance issues.
Lead root cause analysis for supplier quality issues, using tools such as 8D, 5 Whys, Fishbone, and Failure Mode and Effects Analysis (FMEA). Ensure corrective actions are implemented effectively to prevent recurrence.
Perform regular audits of supplier quality systems and manufacturing processes, both for new and existing suppliers, to assess capabilities and compliance with quality requirements.
Participate in the qualification process for new suppliers, ensuring alignment with quality, regulatory, and customer requirements.
Engage suppliers early in the product development process to ensure quality and manufacturability considerations are incorporated into designs.
Work with suppliers and internal engineering teams to ensure product designs are optimized for manufacturability and quality.
Review and approve PPAP submissions, including control plans, process flow diagrams, and FMEAs
Lead or support improvement projects focused on reducing defects, optimizing processes, and enhancing supplier quality using Lean Six Sigma methodologies.
Monitor and reduce the cost of poor quality associated with supplier defects. Collaborate with suppliers on corrective actions to minimize rework, scrap, and quality-related delays.
Conduct risk assessments to identify potential risks within the supplier base. Implement strategies to mitigate high-risk suppliers, including developing alternative sourcing when needed.
Manage and disposition of non-conforming materials from suppliers
Review ECOs, deviations, contracts, drawings, routings, purchase orders, and various related production and development plans for quality requirements
Train, coach, and mentor quality engineers as subject matter experts in key technical areas
Review incoming supplies and finished goods from vendors to check for defects, ensure quality, and authorize the release.