• 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. 

• All potential onePLM change control activities and MasterControl activities.

• 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) 

Required qualification:

• B.Tech (Electronics/Electrical/Mechanical/Biotech) with 3-7 years of experience in Quality / Engineering / Manufacturing environment, preferably from medical industry with ISO 13485 auditor certification is a plus. 

• Trained on Trackwise enterprise system, PLM would be an advantage. 

• Intermediate level ability to use most MS tools (Word, Excel, PowerPoint, etc.) 

• Supplier Quality Processes/ Tools - Working knowledge of basic and advanced Quality tools such as; Six Sigma, SPC, FMEA, Control Plans, Root Cause Analysis, Poke Yoke, Kaizen, Lean Manufacturing etc. 

• Executes/ Masters & implements/ improve all supplier quality tools/ Processes. Trains supplier in these tools effectively. 

• Commodity Domain Knowledge – Strong Knowledge & understands technology, regulatory requirement related to product, system & services. Determine supplier technical abilities based on these knowledges.