Project engineer Quality
Stryker
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Job Description
- 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.
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
- 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
About The Company
Stryker
Stryker is a global leader in medical technologies and, together with our customers, we are driven to make healthcare better. We offer innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. More information is available at stryker.com and careers.stryker.com. Facts: ● 2023 Sales: $20.5 billion ● Industry: Medical Instruments & Supplies ● Employees: 52,000 worldwide ● 40 years of sales growth leading up to 2020 ● 44+ Manufacturing and R&D Locations Worldwide ● $1.4 billion spent on research and development in 2023 ● ~12,900 patents owned globally in 2023 ● Products sold in ~75 countries ● Fortune 500 Company ● 7 consecutive years as one of Fortune's World's Best Workplaces Stryker’s social media community guidelines: https://www.stryker.com/content/m/legal/social-media-community-guidelines/en/index.html Notice Regarding Employee Conduct on Facebook/LinkedIn Meta/LinkedIn does not permit employers to verify or validate “employees” in the (META: “Works at” LinkedIn: “Experience”) section of users’ profiles. Please be aware that the views expressed by individuals on their personal accounts and do not necessarily represent the views of our company. If you encounter any issues with a person claiming to be our employee, we recommend using the “Report Profile” feature. If you’d like to report concerns to our Ethics Hotline, you may do so at: https://app.convercent.com/en-us/LandingPage/b6bb4e84-9fcb-ea11-a974-000d3ab9f296
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