Job description
Work Flexibility: Hybrid
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
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.
- Willing to travel in support of business needs to different geographical locations.
- 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 Know how of Manufacturing processes like welding, Molding, Machining etc.
- 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%