31 Jul
|
Stryker
|
Haryana
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.
- Robust 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%
📌 Quality Engineer (Haryana)
🏢 Stryker
📍 Haryana