Experience

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  Integra lifesciences

  Nov 2012 - Mar 2013

  Quality control laboratory technician

  • Held responsiblity for Integra’s in-process, stability, and finished goods testings.• Reported to senior quality management on the investigation/ progression of validation studies and data analysis, out of specifications (OOS) and non-conformance (NC) events. • Assisted Quality Engineering on NC investigations, Engineering and Validations Studies.• Trained and assisted Junior technicians.

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  Accriva diagnostics

  Apr 2013 - Jan 2017

  • Lead Comprehensive Quality Improvement Program (CQIP) on Cuvette product lines, assess and improve deficiencies, results reported to executive leadership.• Subject Matter Expert on Hemochron Cuvette Line and Hemochron Response Tube line. • Owned and Completed multiple Investigation reports (IR) and Non-Conformances. • Coordinated with Mechanical Engineering teams, trouble shooting (Ishikawa/ 5M) • Supported operations/ Manufacturing with the revision of BOMs,Routings and work instructions• Trained and supervised groups of 6-10 production operators Show less

  • Senior Engineer

    Aug 2016 - Jan 2017

  • Engineer II

    Aug 2014 - Aug 2016

  • Engineer I

    Apr 2013 - Aug 2014
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  Instrumentation laboratory, a werfen company

  Jan 2017 - now

  • Subject Matter Expert on Risk Management (ISO 14971:2019)• Internal Auditor Front Room / Backroom support (ISO 13485:2016). • Managed and Trained direct reports (engineers) on root cause investigation, failure analysis, statistical techniques, sample size.• Maintained Healthy Process Risk / Product Risk Management Reports & Assessments• Assisted in Company IVDR certification and compliance. • Lead CAPA Investigations successfully mplement corrective and preventative measures. • Subject Matter Expert on Hemochron Cuvette Line and Hemochron Response Tube line. • Coordinated with Engineering teams for trouble shooting (Ishikawa/ 5M) Show less

  • Staff Engineer

    Jul 2020 - now

  • Senior Engineer (Accriva)

    Jan 2017 - Jul 2020
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  Kite pharma

  May 2023 - now

  Senior quality engineer

  • Leading enterprise, Cross functional and local computer systems validation teams / activities, in providing approach, methodology and deliverables.• Provide equipment, system, software, and facility qualification guidance and strategy during project planning and development phases.• Partnering with project teams to provide solutions for validation of systems following a risk based approach.• Providing Quality Oversight in change control activities to ensure technical and document impact assessments are performed in a compliant manner and the regulated systems are maintained in a validated state. Show less