Dublin, CA *****
March 26, 2012
Dear Hiring Manager:
I am an enthusiastic, energetic, value-driven Quality Assurance & Regulatory Compliance Manager with more than 17 years experience who leads by example and posses intangible negotiation skills at the table. As a leader in the Quality & Regulatory Department, I tactically tackle every daily Quality operations with benefit-risk sound business decision to help the organization for long-term. I can effectively utilize my skills and implement standard practices in Quality measurement & Regulatory requirements of finished products.
Through many years of professionally practicing Quality & Regulatory of finished Class II and III medical devices (e.g., MRI, CT, DNA analyzer, PCR & Diabetes Diagnostics, etc., I have acquired untouchable skills to strategically pass FDA inspection and ISO Notified Body audits ensuring that our continuous Quality System will always produce Highest Quality Products. With the acquired knowledge and experience over years of dedication and perfection, I am always happy and willing to mentor my Document Control, Quality, and Regulatory staff in the Quality processes that I have effectively developed and adequately implemented for suitability of the organization. My researching ability in FDA regulations and ISO standards, and expert interpersonal skills using advanced software tools such as Agile, Oracle, SAP, Pilgrim, Rational Pro, Minitab, etc. will surely show positive results.
I’m open to negotiation and contingent upon a variety of factors such as the responsibilities of the position and the benefits offered.
I would welcome the opportunity to further discuss my skills and this position. If you have questions or would like to schedule an interview, please contact me by phone or email. I look forward to hearing from you.
3770 Ferncroft Way, Dublin, CA 94568, 408-***-****, firstname.lastname@example.org
● Acting Management Representative hosting audits / inspections from FDA, Notified Bodies and clients
● Maintaining current ISO certifications (9001, 13485, 14971, 14001), and Cal/OSHA, FDA and CAFDB registrations
● Built and supported Class II and III Medical Devices: Abbott Diabetic Diagnostics, Carl Zeiss Lasik, Phillips MRI and CT, Roche PCR Diagnostics, Qiagen MDX, Optimedica Pascal Laser, Balloon Catheter, Health Hero Buddy System, AED
● Tactical daily operations of end products for the following programs: design control, QA/QC, risk, validation, CAPA/complaint, training, compliance, and submission
● Software documentation and validation: SAP, Oracle, Agile (CFR Part 11), Pilgrims (CFR Part 11), Telelogic Doors (CFR Part 11), Rational Pro (CFR Part 11), homegrown MES (CFR Part 11), WMS, and homegrown CAPA/complaint handling (CFR Part 11), Minitab 16
SKILLS AND ACCOMPLISHMENTS
ISO 9001:2008 Certification, All FAB Cert. from DQS UL 8/19/11
CAFDB Inspection, Victron - Pass cGMP inspection 02/2010
ISO 9001, 13485, 14001 certifications 03/2010
Victron -Pass Quality and Environmental Management System audit from DQS UL
ISO 9001, 13485, 14001 certifications 10/2008
Flextronics - Pass QEMS audit from TUV SUD
FDA Inspection, Sanmina-SCI - Pass cQMP inspection 04/2006
ISO 9001, 13485, 14001, certifications 03/2006
Sanmina-SCI - Pass QEMS audit from TUV Rheinland
All FAB Precision & Mecpro, San Jose, CA 1/2011 – Present
Manager, Quality Assurance
● Acting Management Representative
● Establishing Quality Systems to ISO 9001 standards
● Trained personnel on ISO 9001
● Established continuous improvements on Quality Control, Process Verification and Validation, Quality Systems, Risk Management, Corrective and Preventative Actions, Internal Audit and regulatory requirements
● Managing Quality & Document Control
Blowfish Information Technology Inc., Sunnyvale, CA 03-12/2008, 10/2009-12/2010
Director, Quality Assurance
● Established and audited Quality System to ISO 9001 & ISO 13485 standards
● Trained personnel on ISO 9001, ISO 13485, ISO 14971, Auditing, Risk Assessment, & Validation Documentation, Interacted with regulatory agencies (state & local government) and Notified Body as Official Correspondent
Victron Fremont, CA 12/2008 – 09/2009
Manager, Regulatory & Quality
● Established, documented, & audited Lean Six Sigma in Victron’s Quality, Regulatory, and Environment System in accordance with FDA CFR QSR, ISO 9001, 14001, 13485 standards, and ITAR
● Established, documented, & audited Lean Six Sigma in Victron’s Quality, Regulatory, and Environment System in accordance with FDA CFR QSR, ISO 9001, 14001, & 13485 standards
● Daily management of QA/QC, validation, and Regulatory compliance
● Development, implementation, and audit of Quality, Regulatory, & Environmental strategies & plan, Complaints/CAPA system, Validation, Auditing programs, 6S, SPC
● Validation of ERP/MES system; Quality Collaboration System
● Acting as Management Representative / Official Correspondent
● Manufactured: Carl Zeis Lasik, Becton Dickson PCB, Thermo Fisher Spectroscope
Sanmina-SCI, San Jose, CA 06/2004 – 03/2008
Manager, Regulatory Compliance
● Established Quality and Regulatory strategies & plan
● Tactical daily operations: QA, risk assessment, validation, compliance, preparation and submission of 510Ks and IDE technical files
● Established plans, policies and procedures: FDA QSR, EUMDD, CMDR, ISO 13485, 14001, & 9001
● Interfaced with regulatory agencies and Notified Body as an Official Correspondent
● Audited Quality Management System to FDA QSR, CMDR & ISO 13485
● Trained personnel on cGMP & GDP, FDA’s QSR, CMDR, EUMDD & ISO 13485 compliance, and specifics such as internal auditor, design controls, process validation, etc
● Validation Accomplishments: SAP, Oracle, Agile, Pilgrims, CAPA, MES
● Assisted in successful 510(k) and IDE submissions, as well as technical file and design dossier compilation
● FDA annual registration of the establishment & device listing
● Implementation of Quality System, Process Validation, CAPA, 6S, Reliability, DRT, CSI, ISO, QBR, & IA at plant level
● Manufactured Class II and III medical devices: Philips MRI and CT, Abbott Diabetes Diagnostic, Health Hero Buddy System, Optimedica Pascal Laser, Balloon Catheter
Roche Diagnostics, Pleasanton, CA 10/2000– 06/2004
System Integration Scientist
● Worked Environment (GLP/GCP): Preparation of IVDs, i.e., HIV, HBV, HCV, HPV, G/CT assay in Class C Laboratory; Executed Multiplex PCR assays in Clinical Laboratory in Class C Laboratory
● Conducted Verification & Validation, Risk planning & DHF documentations: LIMS – PCR Technology, Amplilink
● Developed and implemented DB (i.e. Excel and Access), multiplex assays (HIV, HBV, and HCV)
● Accomplishments of 510k submission: AMPLILINK & IDE submission: HIV-1 Test System Developed Clinical Studies & Medical devices (i.e. Qiagen MDX, COBAS AmpliPrep / TaqMan)
EDUCATION DeVry University Fremont, CA
MS, Information System Management
Cal State Hayward Hayward, CA
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