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Supplier Quality Engineer
Katalyst Healthcares & Life Sciences
🇬🇧 United Kingdom | 🇺🇸 United States
On-site
2 days ago
- Risk Management
- PFMEA
2 days ago
Not enough detail in this posting to match
- Responsible for achieving a state of high-quality performance at our Supplier partners through the application and practice of Advanced Product Quality Planning 'APQP' , Supplier Qualification (Audit, Quality Agreement/Change Notice Agreement), and continuous monitoring the performance supplier to drive zero defect through Supplier Corrective Actions and notification.
- You will fill a high-profile, cross functional position and play an integral role enabling development and production flow of Philips IGTD's critical supply base.
- You will work in close coordination with Product Engineering, Supply Chain and Production and Suppliers to execute effective, creative and smart supply chain strategies to achieve production goals.
- Perform Process Validation and Verification across Spectrawave IGTD portfolios for Consoles and Catheter parts.
- Collaborate with R&D and Quality Design Assurance in Design for Manufacturability and Part Risk management per DFMAE and PFMEA.
- Perform Process Validation , Verification, Test Method Validation, and assess CTS/CTQ criteria per APQP requirement for +700 parts.
- Support Supplier Qualification including Audit, Quality Agreement and Change Notice Agreement.
- Perform Problem solving in the case of FAI and APQP failure.
- Deep dive Value Stream mapping across process.
- Conducts thorough investigations of defects to determine if they are supplier-caused and implement corrections using the SCAR process.
- Proactively manage, monitor, and troubleshoot supplier-related issues for quality of components, sub-assemblies, and assemblies includingmonitoring trends and managing Supplier Improvement and Supplier Quality Performance Monitoring.
- Providing Quality oversight of product/process change requests from suppliers (SICRs: Supplier Initiated Chage Requests), ensuring appropriate regulatory review and adequate validation to support requested changes including following our APQP process and leading process validation, as necessary
- Develop and oversee process validation plans, including equipment qualifications, with suppliers and lead continuous improvement projects based on process/product trends, customer complaints, industry standards, and government regulations.
- Bachelor's degree engineering (Master Degree is plus).
- 3+ years of engineering experience (Manufacturing Engineer and/or Product Quality is plus).
- In-depth product manufacturing and quality experience in process validation and verification Subject Matter in IQ, OQ, PQ
- SO, 13485 Lead Auditor certified is plus.
- Experienced in plastic, metal, electronics commodities.
- Strong written, oral and interpersonal skills to be able to effectively interface interdepartmentally and complete assignments with accuracy and a high attention to detail
Supplier Quality Engineer · Katalyst Healthcares & Life Sciences