Quality Engineer /Manager

Robert Blackman

**** ****** ****** *****, ***** Rosa, CA 95404 707-***-****

a1b5sa@r.postjobfree.com

Employment Objective

Quality Systems Coordinator or Related Quality Assurance Positions

Combines 20+ years of progressively responsible experience in:

 Internal/External Quality Auditing * ISO 9001/13485 Registration Leadership/Certification Achieved

 Authoring Quality Manuals, Procedures, Protocols, Work Instructions, Guidelines & quality records

 Customer Complaint/RMA Processes * Instruction-Counseling in ISO 9001/13485 Internal Auditing & SPC

 Corrective/Preventive Action * Quality Indices Reporting to Management

 Management Review/Representative * Regulatory Compliance/FDA Protocols

 Inspection & Test * Microsoft Proficient

 Training/Safety Administration * Risk Analysis

Quality Assurance Experience

Quality Systems Coordinator, SMC Ltd., Santa Rosa CA (2004 to 2010)

• ISO 13485: 2003 Registration/FDA Compliant CORE Team Leadership/Certification Achieved

• Interfacing with customers, suppliers and company personnel to resolve quality issues effectively and in a timely manner.

• Coordinates Internal Audit & Corrective Action quality systems.

• Training Administrator for QMS Procedures, Work Instructions & related forms.

• Management Review data analysis and presentations.

• Regulatory Compliance for FDA Protocols, PAL Ordinance 169, MSDS, RoHS/REACH, NAFTA, and Safety.

• Continuous Improvement Committees.

• Safety Coordinator.

• Cleanroom coordination and test.

• Originate or revise procedures, work instructions, quality record forms/logs, work aids & guidelines.

• Process improvement projects.

• Trained company personnel on ISO 9001/13485, CAPA, Internal Auditing, Root Cause Analysis, Risk Analysis, & Training Processes.

Quality Systems Coordinator, JDSU (Lasers-Optics-Display), Santa Rosa CA (2000-2004)

• Revised the internal audit process and rebuilt audit team to deliver high quality and on time audits. Received acclamations from outside auditors.

• Coordinated the corrective/preventive action system in which the cycle time to closure continuously improved and the issues at hand were effectively resolved.

• Managed the customer complaint process and reduced the number of open complaints by 90%. Additionally, division goals for cycle time to closure were met each quarter.

• Served on the ISO Leadership Team by counseling division personnel and coordinating all the Quality Information Boards throughout the division. All ISO audits were a success.

• Reported on quality indices, to division management on a weekly, monthly, and quarterly basis with both written and oral presentations.

• Reconstructed a defunct inspection stamp system.

ISO Coordinator-Quality Assurance Technician, Xandex Inc. Petaluma, CA (1985-2000)

• Conducted electro-mechanical incoming, in-process, and final inspections. Authored inspection instructions and set up quality record systems.

• Built and managed both the internal audit and corrective/preventive process.

• Directed supplier audits that lead to improvements in material quality and on-time-delivery.

• Participated on ISO registration team from start to finish. ISO registration was achieved.

• Coordinated RMA/Customer Complaint processes. Cycle time to closure showed continuous improvement throughout tenure.

• Set-up document control system for quality procedures and work instructions.

Related Education:

• Internal Quality Auditor course, Neville-Clarke Training, Santa Clara, CA (1994)

• Implementing ISO 9001 Standards, SEMI, San Francisco, CA (1995)

• Geometric Dimensioning and Tolerancing course, ASQ, San Jose, CA (1998)

• TL 9000 Quality System Metrics, Stat-A-Matrix Institute, San Francisco, CA (2000)

• ISO 9001:2000 Revisions Class, National Standards of Ireland, Santa Clara, CA (2001)

• Lean/Sigma Training, Inter-Company Training, Santa Rosa, CA (2002)

• Internal Quality Audit Certification, ASQ, Santa Rosa, CA (2002)

• ISO 13485: 2003 Tutorial, Peak Process, Windsor, CA (2005)

• Root Cause Analysis, Inter-Company Training, Santa Rosa, CA (2006)

• Risk Management for Medical Device Organizations, Peak Process, Santa Rosa, CA (2006)

• Risk Management-OTS & OTSS Software – Part 11 Considerations, Peak Process, Santa Rosa, CA (2006)

Education

Beverly Hills High School, General Studies, Graduated

San Fernando Valley College, General Studies, Graduated, A.A. Degree

Sonoma State University, U.S. & International History Studies

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