ASQ Silicon Valley Section 0613. - William Riley

William Riley - Quality Systems Manager

WILLIAM RILEY
San Mateo, CA 94403-3941                               650-544-1166 (m)
http://www.linkedin.com/pub/1/4b/406                          This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

OBJECTIVE:                    Quality Management opportunity in biotechnology
O 9001:2000 ISO 13485:2003 14971 FTA
QUALIFICATIONS
A “Hands-on” Quality professional with 10+ year’s management and development experience in Quality and regulatory programs with an emphasis on: Compliance, Process Improvement; Root Cause Analysis, Risk Analysis and Customer Service. Excellent at identifying and resolving issues using systematic analysis and problem-solving skills. Managed ISO/cGMP compliance and coordinated QA/QC activities of a medical device Quality System.

ACCOMPLISHMENTS
* Achieved a 20% reduction in customer complaints for a class I medical device.
* Improved compliance through revision/implementation of 60% of the QS processes.
* Replaced 3% failures in 9 months without loss of customer's confidence.
* Reduced annual inspection costs $150K through parts certification program.
* Improved compliance by implementing Engineering standards for product documentation.
* Reduced warranty accrual requirement by 50% through a defect tracking method.
* Reduced warranty rate by 35% through a defect tracking method.
* Reduced product nonconformance level during 4 years of double digit sales growth.

TRANSFERRABLE SKILLS
Management
* Established effective partnerships with internal staff to facilitate resolution of compliance / quality matters, opportunities for quality process improvement.
* High commitment to assignments and capable of working independently
* Responsible for the Division’s Executive Management Reviews (EMR).
* Ensured Process Control requirements are met; responsible for product and process validation protocols, reports and testing
* Monitored Non-Conforming Material trends and ensured Corrective Action was taken.
* Maintained Supplier Quality programs, investigations and implemented best practices.
* Responsible for tasking, monitoring, reviewing employees and maintaining project schedules.
* Developed policies and procedures to affect operational and compliance status; lead and mentored quality assurance associates and management on quality systems requirements and practices.
* Built and lead the quality assurance function teams that achieved reduced warranty rates, improved customer satisfaction, increased process efficiency, and improved compliance.

Quality
* Knowledgeable of the 510(k) & cGMP, ISO 9001/13485, PAL, TGA, CMDR and MDD/IVDD, CE conformance reviews, ISO 14971 Risk Management, QA/QC plans and processes.
* Managed timely Complaint, nonconformity, returned goods and CAPA activities; reporting, processing, database management and data trending.
* Built and maintained the Internal Quality Audit system; conducted internal and supplier audits.
* Provided global quality system training for medical device (US & International) regulations

Technical
* Provided product support; reviewing engineering changes, labeling, promotional material, product changes and documentation for changes requiring government approval.
* Developed SOP structure to identify ISO/Regulatory requirements and maintain configuration control.
* Conducted FTA, FMECA, Root Cause Analysis, DFM review, data analysis, trending, and complaint investigations and. CE conformance reviews and participated in the design release process.
* Proficient computer skills including Excel, Word, Visio, Access and PowerPoint programs

PROFESSIONAL EXPERIENCE

Manager, Quality Control, ULTRA CLEAN TECHNOLOGY                   7’07 to 11’07
* Managed in-process QA in a 5 building machine shop and GMP device assembly operation
* Provided supervision to skilled non-exempt/exempt employees; training, and coaching.
* Managed training, inspection preparation, and maintenance of the ISO 9001 Quality System.

Manager, Quality, STACK Plastics                               9’06 to 7’07
* Managed training, inspection preparation, and maintenance of the ISO 9001 Quality System.
* Implemented, supported, and sustained quality system; procedures, training, auditing, and support.
* Developed and implemented procedures to monitor quality and customer satisfaction improvements.
* Established device and product qualification requirements.
* Participated in continual improvement by changes to SOPs, forms and manufacturing processes.

Manager, Quality and Regulatory Affairs, TECAN SYSTEMS/CAVRO           12‘97 to 5‘05
* Served as the Management Representative for the site, reporting to the President.
* Coordinated product quality, internal and supplier quality auditing, inspection, compliance and business process initiatives with senior operating management.
* Managed the risk management activities performed by Quality Engineers.
* Responsible for Change Order Review, implementation control and validation for products to identify hazards and risks, and to review the mitigations and effectivity.
* Experienced with FDA Class I fluid systems, Class II blood test systems, and hardware and software validation.
* Implemented and monitored the CAPA System; non-conformance, CAPA and Investigation tracking, trending and closure.
* Directed a continuing review of the quality control program and formulated revised procedures to effect improvements, reduce cost and enhance efficiency.
* Implemented, supported, and sustained quality system; procedures, training, auditing, and support.

Director of Quality Systems, AMPRO COMPUTER.                  8‘95 to 11’97
* Served as the Management Representative for the site
* Responsible for implementing, maintaining, and quarterly reporting on ISO 9001 QS compliance
* Conducted supplier relations; MRB, audit, CAPA, qualification, inspection planning.

EDUCATION
BSEE, DeVry Institute of Technology, Phoenix, AZ
ASQ; QSIT Training, ISO 13485:2003, ISO 9001:2000, Process Analysis, CAPA, etc.

    PROFESSIONAL AFFILIATIONS
RAPS,
ASQ - Biomedical Division,
ASQ-Silicon Valley Chapter,
Bio2Device Group

VOLUNTEER AFFILIATIONS
Second Harvest Food Bank,
CSIX Peninsula Board,
CSIX,
ProMatch.
Bio2DeviceGroup,

CLEARANCE:   Prior SECRET clearance at Litton (L3) and Varian.
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William Riley QAM Resume 02042008.doc       Page 1 of 2