Responsibilities:

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• Extensive experience in Facilities, Utilities and Equipment validations
• Create Master Validation plan (MVP)  in coordination with differing stakeholders
• Hands-on experience in Method Trans Plan Process Validation (IQ /OQ /PQ), Validation performance and Reports.
• Working on sample size determination, creating sample size for Testing’s, for Design Verification, Validation, Process Validation and Test Method Validation
• Hands on experience working on Validation reports for the Manufacturing site that are moving from one place to another. This includes Facility Validation as well.
• Hands on experience on drafting Protocols, Testing, Data Analysis and Test Reports
• Extensive Experience on using Minitab for Data Analysis, R&R Analysis after Test Execution
• Understanding on Software elements would be an added advantage
• Knowledge on IVDR and DHF Remediation also will be an added advantage

Requirements:

4-7 Years’ experience in the Combination of Mechanical & Manufacturing, with a Medical Devices background.

• Good understanding of Requirements analysis (Customer Reqs, Technical Reqs, Functional /Product Reqs), Traceability Matrix, DHF Remediation, and Risk Management with FMEA working.
• Experience with QC Tools and Statistical Methods
• Understand Product BOMs and assessments with reference to information available in PLM/Other Repository
• Working closely with customer counterparts and understanding their requirements and working in a collaborative mode. Understand the customer requirements and suggest alternative feasible concepts.
• Good knowledge of various manufacturing processes like Machining, Sheet Metal, Plastics, and DFM/A.
• Familiar with Engineering Change Orders and Engineering Change Notes
• Proven track record of problem-solving
• Knowledge in Mechanical Design, Bill of Materials, Product Life Cycle stages
• Provide Project status updates to the workgroup, tracking the overall project implementation.
• Good Communication and documentation skills. Good knowledge of MS PowerPoint and Excel