About this role
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%