Senior Manufacturing Quality Engineer- Reagents

10 - 14 years

12 - 16 Lacs

Posted:-1 days ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

  • Liaise with the reagent contract manufacturer and represent Beckman Coulter Quality in the interaction with the contract manufacturer and is responsible for the generation, analysis and reporting of quality metrics to relevant personnel and to ensure on-going improvement programs are put in place.
  • Lead cross functional teams providing Quality guidance and guide in the determination of appropriate NC root cause analysis and implementation of effective corrective actions.
  • Responsible for the Rework process, ensuring relevant documentation is prepared, reviewed and approved as per company procedures as well as completing Acceptable Quality Level (AQL) inspections prior to product disposition.
  • Execute the Stop Ship process for finished product released to the market, in the Oracle system, ensuring process is compliant to relevant company procedures and perform CAPA (corrective and preventive action) activities and document in the CAPA system if required.
  • Review & Approve document Change Controls (CCFs) and Equipment Change Controls (ECCs) ensuring Good Manufacturing Practices are maintained and comply with company procedures.
  • Author relevant procedures, Review/Approve documentation (e.g. protocols, reports) ensuring compliance to applicable procedures and provide Quality expertise during the product life cycle.
  • Review & Approve Certificate of Analysis(COA) for the finished goods.

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