Work Flexibility: Hybrid
Who we want:
- Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
- Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
- Curious learners. Engineers who seek out cutting-edge research and information to expand and enhance their ability to develop software.
- Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
- User-focused creators. Engineers who design with the user in mind, developing solutions that help change patients’ lives.
- Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
- Motivated product launchers. Engineers who bring strategic direction and drive for execution to ensure products are developed and launched with precision.
What You Will Do:
Roles and responsibilities :
- 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 and the CRT
General Skills :
- Basic Knowledge in statistics
- Good communication skills
- Strong team player
- Good understanding and ability to work with Microsoft Office
- Basic understanding of manufacturing processes
- Fluent in written & oral English
- Willing to travel in support of business needs to different geographical locations
- Basic understanding of project management
- Good interpersonal skills
What You Need
Professional Requirements- Required:
- Honors Bachelor’s degree in Engineering or Science fields or equivalency.
- 4 to 5 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
Personal Competencies
- Must enjoy working in 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: 0%