Project engineer Quality
Stryker · Gurugram, Haryana, India
Full-time · Mid-Senior level · Posted 11 days ago
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% Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.