Project engineer Quality

Reposted 5 Hours Ago
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Gurugram, Haryana, IND
In-Office
Mid level
Healthtech • Other • Robotics • Biotech • Manufacturing
Together with our customers, we're on a mission to make healthcare better.
The Role
The Project Engineer Quality will manage Supplier Initiated Change Requests, ensure supplier compliance, maintain databases, and support project initiatives while collaborating with stakeholders.
Summary Generated by Built In
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%

Skills Required

  • 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 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

Stryker Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Stryker and has not been reviewed or approved by Stryker.

  • Healthcare Strength Healthcare coverage is described as comprehensive, with multiple medical plan options and added protections such as critical illness, accident, and hospital indemnity, plus mental health resources. Wellbeing programs, onsite gyms, and fitness/nutrition classes further reinforce the perceived strength of health benefits.
  • Retirement Support Retirement offerings are seen as strong, highlighted by a competitive 401(k) plan with company matching and potential discretionary contributions. These elements are often viewed as valuable pillars of total rewards.
  • Strong & Reliable Incentives Variable pay is viewed positively, with annual bonuses and sales commissions often lifting total compensation. Incentive plans are seen as a meaningful contributor to pay satisfaction in roles where performance drives earnings.

Stryker Insights

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The Company
HQ: Kalamazoo, MI
51,000 Employees
Year Founded: 1941

What We Do

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers 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 130 million patients annually. More information is available at www.stryker.com. Together with our customers, we are driven to make healthcare better.

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