Quality Project Engineer

Project engineer Quality Work Flexibility: Hybrid or Onsite What you will do: Support the implementation of process improvements to Corporate/Site/Division Supplier Initiated Change Request procedures and process. Served as owner, execute, and maintain the electronic systems related to SICRs, and support data alignment (SICR Database & OnePLM SICR Library) Challenge suppliers SICRs forms for completeness and accuracy. Discuss corrections to the form to guarantee a smooth assignment and execution of the change. Own & Execute Supplier Initiated change request (SICR) submitted by Global Suppliers Review Submitted SICRs and challenge suppliers for missing information & required deliverables for approving the change Organize SCRB with Key Stakeholders and get Buy in for Type of change. Review and Approve deliverables submitted by suppliers and coordinate with supplier for any corrections. Execute ECR/ECNs and Promotion requests in OnePLM for Change Approval at Stryker end. Support communication tools to internal and external customers (suppliers/site/division) Monitor and Maintain SICR KPIs. Support Global SICR Initiatives • Well verse in WINDCHILL, ONEPLM, (Equivalent change control systems), SAP (Equivalent ERPs) Design control systems. GD&T, PPAP, APQP, PFMEA, DFMEA, CQA, Validations, design Change controls. What you will need: Required qualification: Honors Bachelor’s degree in Engineering or Science fields or equivalency. 3+ years of experience in manufacturing environment or equivalent. Basic knowledge with GMP, ISO 13485, 21 CFR Part 820 standards Good communication skills. Good knowledge of continuous improvement methodologies Hands on experience of PPAP ,MSA, SPC documentation creation, review and Approval from suppliers. Good Hands on experience of Validation activity – IQ,OQ & PQ Good Hands on experience of PFMEA & Control Plan Preferred qualification: Must enjoy working in a team environment Must demonstrate good collaboration and communication skills. Highly motivated and able to build relationships internally and externally. Must demonstrate multitasking skills as this individual will be responsible for multiple tasks at the same time. The individual should enjoy working in a dynamic and results-oriented team environment focusing on quality, compliance and customer satisfaction Travel Percentage: 10% Experience Level Mid Level