What you will do:
• Ensuring compliance to Supplier Control activities identified by organization.
• 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.
• Conduct Supplier Audits (Product, Process & System) and Facilitate root cause analysis and corrective actions of supplier quality issues.
• Evaluating Quality data to identify process improvement opportunities within the supply chain.
• 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)
• Review development protocols including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Special Process Validations, and Test Method Validations.
What you will need:
Required Qualification:
• B. Tech (Electronics/Electrical/Mechanical) with 2+ years of experience in Quality / Engineering / Manufacturing environment, preferably from medical industry.
• Proficient in advanced power BI applications.
• ISO 9001/13485 certification.
Preferred Qualification:
• 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.
• Strong communication skills. Must demonstrate the ability to communicate up/down and across different levels of the organization.
• Structurally collects facts to base his/her opinions on and ensures data integrity and traceability of data is flawless
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