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Sr. Qa Supervisor Resume

Castro Valley, CA

SUMMARY

Proven track record of leading team efforts in resolving organizational challenges. Strategic thinker with
vision, attention to detail and sensitivity to the bottom-line. Passionately committed to creating and
sustaining robust, streamlined systems that respond to business objectives.

EMPLOYMENT

Sr. QA Supervisor, Confidential, Pleasanton, CA, 4-2007 to present

  • Supervise 15 direct reports
  • Manage the day-to-day inspection activities of the Receiving Inspection Dept.
  • Thorough understanding of Six Sigma, 5S, PDCA, Kaizen and Statistical Analysis
Regulatory Affairs II, Confidential, Pleasanton, CA, 5-2005 to 3-2007 Managed and maintained MDD Technical Files (CE Mark), Establishment Registrations, Device Listings, and Certificates to Foreign Government
  • Conducted internal audits
  • Regulatory advisor for all phases of the Product Development Process
  • Champion for DHF & Risk FDA Remediation Activities
  • Managed & Maintained Design Control Activities for Internal Audits, Risk Management Activities and Design History Files
QA Supervisor / Sr. Quality Assurance Specialist, Confidential, Dublin, CA, 7-97 to 5-2005
  • Supervised QA Inspector Group (Product Release)
  • Managed and led internal audit program
  • Recruited, trained and supervised Internal Quality System Auditors
  • Designed and developed training curriculum for new and existing employees
  • Conducted training on QSR, ISO 9001/13485/14971, CMDR, MDD, ESD and Safety
  • Revised, created and released Standard Operating Procedures (SOPs)
  • Managed all sources of quality data metrics
  • Managed and maintained the CAPA and Complaint System / MDR.
  • Reviewed and approved verification / validation / risk analysis protocols and reports
  • Reviewed and approved Engineering Change Orders (ECOs) and Deviations
  • Maintained the establishment registration and device listings with the FDA
  • Participated in 510k (Traditional, Abbreviated & Special) submissions with regulatory counsel guidance
  • Participated for all FDA, FDB, ISO, CSA, and UL agency audits
  • Participated in Material Review Board Process
  • Participated in Management Review Meetings

Chemist (Team Lead), Confidential, Richmond, CA, 6-93 to 7-97

  • Data analysis/review, authored reports for EPA Pesticide Regulatory (FIFRA) submissions
  • Wet chemistry analysis including Karl Fisher Titration, HPLC, TLC, CHN Elemental Analysis, Atomic Absorption Spectroscopy, UV-Visible Spectroscopy, pH, and extractions

Confidential, Western Research Ctr., Richmond, CA, 4-89 to 6-93

Quality Control Analyst, Confidential, Hayward, CA, 6-86 to 4-89

Safety & Health Analyst II, Confidential, Hayward, CA, 6-85 to 6-86

EDUCATION
B.S., Biological Sciences

SKILLS - Software: Microsoft Windows, Excel, Word, Power Point, Access, Outlook, Project, Explorer, Front Page, Adobe Photoshop, Visio, MANMAN, Lotus Notes, Camstar-MES, Kronos, Agile, BPCS, AS400, IFS, Sharepoint and CatsWeb

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