Senior Quality Audtior

OBJECTIVE: A growth position in Quality area in a medical device industry.

 SKILLS:

  • 6 year experience in medical device industry (ophthalmic and Endovascular)
  • Working knowledge about GMP,GCP, FDA regulations 21 CFR 820, 21 CFR 803, ISO regulations, IDE, PMA
  • Knowledge about both Medical device and Pharmaceutical regulations

 PROFESSIONAL EXPERIENCE

 Endologix Inc., Irvine, California                                                                                     (Nov 2011- Till date)

Senior Complaints Specialists and Quality Engineer

  • Conducted and managed effective and timely implementation of Internal Audit Program.
  • Managed effective and timely implementation of corrective actions for all Quality systems.
  • Coordinates with different departments in managing corrective actions transpired out of CAPA system, NCMR system, and Internal Audit systems.
  • Responsible for evaluation of complaint investigations to determine root cause analysis of failure.
  • Evaluating and Investigating devices associated with complaints.
  • Support third party audits by being Subject matter expert in complaints arena during external audits
  • Provide compliance item and complaints Metric and trending to upper Management.
  • Primary contact for receiving, reporting, documenting, investigating and coordinating responses for all customer complaint activities.
  • Work with Engineers and relevant teams to provide analysis of product complaints to report trends and identify CAPA's.
  • Managing complaints reporting to FDA , JPAL, TGA and EU
  • Established workflow to better manage Reportable events.
  • Established over-all workflow within complaints and auditing group to improve efficiency.

Abbott Medical Optics, Irvine, California                                                                      (Nov 2008 – Nov 2011)

Quality Assurance Specialist

  • Equipment Management, maintaining equipment calibration and maintenance. 
  • Managed complaint handling system. 
  • Routine review of external standards.
  • Maintain NCR and CAPAs as required.
  • Maintain Quality systems, review and initiate document change orders as required.
  • SOP writing , reviewing and training experience
  • Perform training as required related to new or revised documents and procedural changes.
  • Assist with maintenance of the calibration database and ensure that all calibrations are completed in timely manner.
  • Assisted in scheduling and performance of internal audits as appropriate.
  • Assisted with external audits (notified body, state and FDA)
  • Assisted and Maintained supplier management system
  • Conducted supplier audits as appropriate.
  • Performed Quality assurance tests and inspections to support production and engineering projects.

Visiogen Inc, Irvine, California         (Abbott Medical Optics)                                     (April 2007 – Nov 2008)

Clinical Research Associate – I 

  • Developed study documents ( e.g. Source documents, CRFs, Investigators Binders, Regulatory Binder)
  • Designing and Data entry for the CRFs.
  • Managing Data corrections for CRFs.
  • Managed site initiation activities. Ensuring all investigational sites has adequate and appropriate trial materials and documentation. Maintaining all study inventories both at clinical sites and In-house.
  • Assisted site coordinators during IRB submissions.
  • Coordinating applications with IRB/Ethics committee.
  • Maintained and audited Clinical file system.
  • Tracking timely patient visits.
  • Tracking the investigational product.
  • Performed audits on clinical files periodically.
  • Tracking of payments to study sites.
  • Assisted with the audits conducted during the trials – NSAI, FDA-BIMO, FDA-PAI, Site audits.
  • Monitored study sites, to make sure the sites comply with the FDA Regulations. Maintained and updated regulatory documents at study sites. Reviewed monitoring visits reports and resolved action items with sties.
  • Performing Internal audits regularly.
  • Managed randomization during clinical trial for 20 US sites.
  • Maintaining Equipment system for timely occurrence of calibration and preventive maintainenace.
  • Maintain frequent site contact, oversee site progress and track AEs and SAEs

 EDUCATION 

ASQ-CBA Certification (current)                                                                                                                    

 University of Mumbai

Post Graduate Diploma in Business Administration                                                                                    

University of Mumbai

Bachelors in Biomedical Engineering                                                                                                             

ORGANIZATION MEMBER

ASQ – American Society of Quality

OCRA – Orange county Regulatory Affairs

 CERTIFICATION

 University of California Irvine

Certification program – Medical Product Development                                                                             

University of California Irvine

Certification program – Clinical Trials           

REFERENCES – Available upon request

  • ID#: 73105
  • Location: Irvine, CA , 92612

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