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Project engineer Quality

StrykerStryker·Medical Technology

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Posted

16 days

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About the role

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%

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Aplyr's read

Stryker excels in medical technology, attracting professionals passionate about innovation in orthopedics, surgical, and neurotechnology solutions.

Synthesized from recent postings & public sources

What's promising

  • Stryker's innovative products lead advancements in orthopedics and neurotechnology.
  • Global presence offers diverse career opportunities across multiple regions.
  • Strong focus on research and development fosters continuous innovation.

What to watch

  • High competition in the medical technology sector may impact market share.
  • Regulatory challenges can affect product launch timelines.
  • Complex organizational structure may slow decision-making processes.

Why Stryker

  • Stryker's commitment to innovation in medical technology sets it apart.
  • Diverse product range across orthopedics, surgical, and neurotechnology.
  • Strong emphasis on employee development through varied roles and internships.

Aplyr’s read is generated by AI from public sources. Was it useful?

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About Stryker

Stryker is a global leader in medical technology, offering innovative products and services in orthopedics, medical and surgical, and neurotechnology and spine.

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