Quality Engineer

Quality Engineer

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%

Experience Level

Senior Level