Quality Assurance Engineer

Frank Proctor

**** *********** **. *****: 760-***-****

Vista, CA 92081 E-mail: abhfi6@r.postjobfree.com

SUMMARY

Detailed Quality Assurance/Quality Engineering with more than 25 years of

experience in the Medical Device industry. Proven scientific expertise.

Thorough knowledge of FDA/ISO regulations and extensive experience auditing

to the ISO/QSR requirements. Extensive validation experience of

manufacturing processes, scientific electronic instrumentation and

reagents. Expertise in CAPA, Continuous Process Improvement, Root Cause

Analysis, and FMEA. Demonstrated strong interpersonal skills ensuring

effective employee training and mentoring.

WORK EXPERIENCE

ZIMMER DENTAL, INC., Carlsbad, CA 2008 - 2011

Senior Quality Engineer

. Investigated and provided closure for complaints relating to products

with potential mechanical malfunctions or regulatory nonconformance.

. Wrote subsequent CAPA from complaint investigations for discrepant

products.

. Initiated recall documentation for confirmed nonconformance.

. Created the Health Hazard Evaluation (HHE) used for field action

assessments and recalls.

. Resolved problems for key customers, both domestic and internal.

. Received Risk Management training per ISO 14971.

SYNERGEYES, INC., Carlsbad, CA 2007 - 2008

Quality Engineer

. Wrote and conducted process, equipment and software validations.

. Conducted internal audits per ISO 13485 and FDA QSRs.

. Implemented CAPAs in response to internal audit findings.

. Wrote and approved Engineering Change Requests.

ABBOTT VASCULAR, Temecula, CA 2007

Regulatory Compliance Auditor

. Conducted internal audits, supplier audits and GLP audits.

. Audit escort for ISO and FDA audits.

. Review of process validations to ensure compliance to ISO and QSR.

. Review of change orders to ensure regulatory compliance.

PEDI PLASTICS, Carlsbad, CA 2005 - 2006

Quality Manager

. Managed Quality Control and Quality Assurance Departments and personnel.

. Facilitated CAPA program and documentation.

. Ensured GMP, ISO and FDA compliance.

. Documentation control of DMRs, DHRs, blue prints, and drawings.

. Maintained Calibration Logs and Database.

. Worked with customers to ensure customer satisfaction and customer

requirements.

. Facilitated department training and maintained training records.

. Maintained department budget.

Frank Proctor Page Two

BECKMAN COULTER, INC., Carlsbad, CA 1988 - 2005

Senior Lead Quality Assurance Scientist 1991 - 2005

. Developed and initiated the internal audit program as part of ISO

Certification requirements.

. Served as internal audit coordinator from 1993 to 1996.

. Conducted external audits of raw material suppliers to ensure

requirements were met.

. Performed real-time stability testing of products to determine expiration

dating support and/or extension of shelf life.

. Troubleshooting of technical issues with MRB in response to NCMRs then

subsequent Root Cause Analysis with products and employed Risk Analysis,

Statistical Process Control, FMEA and DOE as required.

. Implemented corrective action or preventive actions per ISO and FDA

guidelines.

. Wrote and coordinated validation procedures for new processes and new

products.

. Investigated (OOS) and (OOT) and implemented any CAPA as required.

. Extensive experience with Immunochemistry Systems, Electrophoresis

Systems, Beckman Synchron product line (CX/LX), antibody raw material

performance issues and subsequent processing.

. Interfaced with Manufacturing and Purchasing to ensure quality standards

were met for raw materials and finished product.

. Implemented documentation changes per appropriate SOP to meet FDA and ISO

Standards

. Trained and mentored new employees.

. Provided technical support for R & D in the development of new/enhanced

chemistries and served as QA Reviewer for Design Reviews.

Manufacturing Engineer 1988 - 1991

ADDITIONAL PROFESSIONAL EXPERIENCE

MOBIL CHEMICAL, Beaumont, TX

Lab Technician

HELENA LABORATORIES, Beaumont, TX

R & D Scientist

Production Scientist

CERTIFICATIONS

. ASQ Certified Quality Auditor

. AAMI Certified in Quality System Requirements and Industry Practice

MILITARY EXPERIENCE

. Officer, United States Air Force

Honorable Discharge

EDUCATION

. BS, Biology / Biochemistry, Lamar University, Beaumont, TX

Summa cum Laude

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