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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