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.