QA/QC Engineer

Project engineer Quality

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%

Experience Level

Mid Level