Supplier Quality Engineer - ISO13485 - SAT

STANLEY Healthcare provides over 5,000 acute care hospitals and 12,000 long-term care organizations with enterprise solutions that transform safety, security and operational efficiency. The STANLEY Healthcare solution set enables customers to achieve organizational excellence and superior care in five critical areas: Patient Safety, Security & Protection, Environmental Monitoring, Clinical Operations & Workflow and Supply Chain & Asset Management. These solutions are complemented by consulting, training, implementation and integration services. STANLEY Healthcare is proud to be part of Stanley Black & Decker, Inc. For more information, visit www.stanleyhealthcare.com

• Audit, develop and qualify new supplier
• Develop, validate and approve supplier quality plan for new products or new components development
• Assure supplier products or components quality through quality control and quality improvement at supplier site
• Professionally problem solving for both internal and external customer complaint
• Lead supplier quality ABC improvement thru cross functional team (strategic sourcing & engineering)
• Conduct Quality Audit (SQA) and Social Accountability (SA) to suppliers based on Stanley Black& Decker audit process. Trace improvement plan (CAP) and maintain the audit information into dedicated audit database.
• Perform In-Process Audit (or called as CAPA or Compliance Audit) to the Stanley Black & Decker item be manufactured by the supplier. Follow up and implement corrective action either with the supplier or buy location (division). Maintain the information in dedicated audit database.

• NCMR (or called DMR/notification)
• VOC (voice of customer)
• Warranty

• Address and follow up the open issues after Product Launch (Quality Book/PQP/PPAP).
• Implement Engineering Change from Stanley Black & Decker side
• Request/support Engineering Change (or called REA) from the supplier side
• Root Cause analysis (finish bone, 5W, 8D)
• 6 sigma project development.
• Guide and facilitate Stanley Black & Decker communication platform extended to the supplier side to improve communication related to engineering/quality control/product specification
• Drawing Access through Supplier Connect
• Material declaration (RSDS)
• Packaging Information through Supplier Connect
• Provide and explain Stanley Black & Decker engineering requirements if it is not confidential that includes:
  • EP (Engineering Procedure), ES (Engineering Specification), PS (Process Specification)

• Co-work with Purchasing responsible (Purchase Engineer or Buyer) on developing supplier.
• Co-work with Project Engineer to facility necessary quality concept/requirement in the supplier side. With regional quality manager's dedication, SQE could involve new product development as short/middle term support.
• Co-work with Test Lab to verify the product complied with product specification.

• High school Diploma
• 2+ Years' experience ISO13485.
• 2+ Years Auditing Experience to conduct Supplier Quality Assurance and Supplier Audit to the supplier side

• Additional experiences in auditing and authoring ISO9001, IATF16949, VDA6.3, SA8000 processes.
• Medical Device/Durable Medical Equipment or Industrial background is preferred
• APQP and PPAP and other quality tools
• Problem Solving Skill (Plan, Do, Check, Act (PDCA), 5Why, 8D, Design, Measure Analyze, Improve and Control (DMAIC), LEAN, Six Sigma, Red-X, Kaizen, etc.)
• Project Management
• Ability of using SAP, Minitab, ETQ, etc