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
