Sr. QA Supervisor Resume Castro Valley, CA - Hire IT People

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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Sr. Qa Supervisor Resume

Castro Valley, CA

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