Quality Engineer

Posted Yesterday
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Gurugram, Haryana, IND
In-Office
Senior level
Healthtech • Other • Robotics • Biotech • Manufacturing
Together with our customers, we're on a mission to make healthcare better.
The Role
Own site quality performance and KPIs, manage supplier containment and CAPA, support PPAP and production transfers, drive root-cause problem solving (5-Why, 8D, DMAIC), apply SPC/FMEA/MSA, coordinate engineering change control, and use Power BI/Excel for quality data analysis and continuous improvement.
Summary Generated by Built In
Work Flexibility: Hybrid

What you will do:
  • Ownership for site quality performance and measurement including KPI’s and participate in supplier performance reviews.
  • Support quality issues with site & partner with Internal Customers; Lead effective supplier containment and corrections/corrective actions
  • Hands on experience of PPAP associated with New Product Launches and Management of Production cycles there after (Manufacturing Transfers).
  • Participate in cross-functional teams in the development of new products or changes related to current products in meeting customer requirements.
  • Applies sound, systematic problem-solving methodologies (5Why, DMAIC, 8D, C&E) in identifying, prioritizing, communicating, and resolving quality issues - NC & CAPA.
  • Evaluating Quality data to identify process improvement opportunities within the supply chain.
  • Support on Internal (Site) & External (Supplier) Engineering Change Management & participate in as required in CFT in conjunction with key stakeholders
  • Coordinate Change Management & Control with Suppliers and implement changes at Supplier.
  • Promote the use of continuous improvement methodologies such as Lean, Six Sigma, Poka- Yoke (Error Proofing), Measurement System Analysis (MSA), Statistical process control (SPC) and Process Failure Mode and Effects Analysis (pFMEA)

 

What you will need:Required Qualifications:
  • B.Tech in Electronics, Electrical, or Mechanical Engineering.

  • 4–8 years of experience in Quality Engineering, Manufacturing Engineering, or a related quality function — preferably in the medical device or regulated industry.

  • Demonstrated CAPA ownership experience: root cause analysis, corrective action planning, effectiveness verification, and closure documentation.

  • Hands-on experience with PPAP, control plans, and inspection methods in a manufacturing environment.

  • Proficiency in problem-solving tools: 5-Why, 8D, DMAIC, FMEA, and Cause & Effect (Ishikawa) analysis.

  • Working knowledge of Power BI (dashboard creation and data visualization) and Advanced MS Excel (data analysis, pivot tables, automation).

  • ISO 13485 awareness or auditor certification is an advantage.

  • Experience with Trackwise enterprise QMS or equivalent quality management platform is an advantage.

Preferred Qualifications:
  • Experience working in a Global Capability Center (GCC) environment or supporting global/cross-regional stakeholders.

  • Working knowledge of advanced quality tools: Six Sigma (Green Belt or Black Belt preferred), SPC, FMEA, Control Plans, Poka-Yoke, Kaizen, and Lean Manufacturing.

  • Strong commodity domain knowledge — understands technology, regulatory requirements, and supplier technical capabilities relevant to the product scope.

  • Experience training or coaching suppliers in quality tools and processes.

  • Exposure to AI-enabled quality tools or digital quality platforms is an advantage.

Travel Percentage: 10%

Skills Required

  • B.Tech in Electronics, Electrical, or Mechanical Engineering
  • 4-8 years experience in Quality Engineering, Manufacturing Engineering, or related quality function (preferably medical device or regulated industry)
  • Demonstrated CAPA ownership: root cause analysis, corrective action planning, effectiveness verification, closure documentation
  • Hands-on experience with PPAP, control plans, and inspection methods in a manufacturing environment
  • Proficiency in problem-solving tools: 5-Why, 8D, DMAIC, FMEA, Cause & Effect (Ishikawa)
  • Working knowledge of Power BI (dashboard creation and data visualization) and Advanced Microsoft Excel (pivot tables, automation)
  • Experience evaluating quality data to identify process improvement opportunities within the supply chain
  • Support for Internal (Site) and External (Supplier) Engineering Change Management and cross-functional teams
  • ISO 13485 awareness or auditor certification
  • Experience with Trackwise enterprise QMS or equivalent quality management platform
  • Experience working in a Global Capability Center (GCC) environment or supporting global/cross-regional stakeholders
  • Six Sigma Green Belt or Black Belt, SPC, Poka-Yoke, Kaizen, Lean Manufacturing experience
  • Experience training or coaching suppliers in quality tools and processes
  • Exposure to AI-enabled quality tools or digital quality platforms

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 Multiple medical plan options with HSA support and global mental‑health access indicate broad, accessible care. These features materially enhance the overall value of the total‑rewards package.
  • Retirement Support A meaningful 401(k) company match with potential additional company contribution, alongside an ESPP, supports long‑term savings and wealth building. Documented plan specifics help employees understand eligibility, timing, and vesting mechanics.
  • Parental & Family Support Paid parental and caregiver leave, adoption and surrogacy assistance, and practical supports like breast milk shipping reflect a comprehensive, family‑friendly approach. These offerings address varied family‑building paths and caregiving needs.

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The Company
HQ: Portage, 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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