| Supplier Quality Engineer - Medical Device at Remote, Remote, USA |
| Email: [email protected] |
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From: Khadar, KK Associates LLC [email protected] Reply to: [email protected] We are hiring Supplier Quality Engineer - Medical Device Consultants for one of my client in Location:- Indianapolis, IN interesting candidates please send resumes to [email protected] Contact:- 6146995972 -105 Position:- :- Supplier Quality Engineer - Medical Device Location: - Indianapolis, IN JD:- Supplier Production Parts Approval (SPPA) Analyze/review the effectiveness of preventive and corrective actions. Review root cause investigation according to an established process. Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality Develop, interpret, and implement appropriate process monitoring and control methods consistent with the level of process/product risk. Collect data and execute/conduct various analytical/statistical analyses and interpretations as part of process improvements and day-to-day support. Document, justify, review, or analyze whether a proposed change to a process will not enhance the risk level in some way beyond the capability of current controls or whether a change will result in potential non-compliance to a required standard such as the QSRs Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine the effectiveness of these techniques on previously implemented improvements Interface with Manufacturing/Process Engineering, R&D, and Regulatory departments to resolve process issues and implement changes. Apply knowledge of process control tools, statistical sampling, and other analytical techniques to maximize the quality and flow of products through the production line. Identify, analyze, and manage risk through the product life cycle with the use of FMEA and other risk management tools. Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through the implementation of solution and effectiveness monitoring. Execute equipment qualification and process validation project(s) KK Associates LLC. 8751 Collin McKinney Pkwy, # 1302, McKinney, TX 75070 555 Metro Place North, Suite # 100, Dublin, OH 43017 Direct: +1 614-699-5972 | Fax: (614) 413-3428 Email: [email protected] Keywords: rlang Ohio Texas Supplier Quality Engineer - Medical Device [email protected] |
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| 07:01 AM 20-Feb-25 |