William Riley 650-572-1163 (h)
San Mateo, CA 94403-3941 650-544-1166 (m)
w.riley@comcast.net
OBJECTIVE: Quality Manager / Process Analyst
SUMMARY:
Quality Manager / Process Analyst with 10+ years experience with medical device quality systems. Business and quality problem solver that reduced
warranty rates, improved customer satisfaction, increased process efficiency, and improved compliance. Effective "hands on" manager and team builder,
with manufacturing operations experience.
SKILLS:
- Trained employees in QSR, ISO 9001:2000, ISO 13485:2003 and CMDCAS requirements.
- Familiar with the general FDA & GMP regulations, Japanese PAL, Australian TGA, and European Union EU Medical Device conformance review and
approval process to support compliance.
- Familiar with the general compliance requirements of IVDD, MDD, IEC 60601 Medical Electrical Equipment, IEC 61010 Laboratory equipment, ISO
14971 Risk Management, CE marking requirements and designation of EU representative.
- Mentored functional managers on quality systems and practices.
- Skilled at conflict resolution, problem solving, effective meetings.
- Excellent verbal and written communication and interpersonal skills.
- Skilled at MS Office Suite and Visio software.
- FTA, FMECA, Root Cause Analysis, DFM, data trending, and complaint investigation.
- Developed key quality metrics for CAPA, audit, complaints and service level.
- Managed the QA department and coordinate all activities ensuring compliance
- Reported and tracked deviations for quality standards, make recommendations
- Evaluated customer complaints, analyze and ensure corrective actions
- Participated in new product development ensuring QA
- Conducted ISO Internal Audits / GMP Audits, interfaced with agencies facility inspection
- Strong analytical & decision making skills, team player, detail oriented
EXPERIENCE:
Manager, Quality and Regulatory Affairs, TECAN / CAVRO (120 personnel) ‘97 to ‘05
- Improved compliance through revision of 60% of the Quality processes. Identified compliance gaps and developed site compliance plans.
- Achieved a 20% reduction in customer complaints within product support areas through gathering and analyzing data.
- Increased inspection acceptance rate from 65% to 95%. Enforced supplier corrective action and expedited reject material returns.
- Managed seven people: four Quality engineers, two technicians and two inspectors, and served as a member of an International Global Quality Team.
- Improved receiving inspection efficiency by 50% for syringes, valves and PCBA. Developed consistent test methods, approved by design and
manufacturing engineering.
- Monitored manufacture of products, assured compliance with DMR, and assured maintenance of a complete and correct DHR.
- Managed training at multiple sites in the QSR, including inspection preparation, QSR (GMP), ISO 13485, general FDA, and maintenance of the Quality
System.
- Replaced 3% reliability failures within 9 months with little impact to customer shipments and without loss of customer's confidence. Implemented burn-in at supplier's vendor location, screening test at supplier, accelerated manufacturing burn-in and recall.
- Managed Quality in the Design process for class I /II regulatory compliance.
- Administrated ISO registration, registration audit activities, customer quality audits, Corrective/Preventive Action system, internal and external supplier audits, etc.
Director of Quality Systems, AMPRO COMPUTER. (85 personnel) ‘95 to ’97
- Achieved acceptance rates of greater than 97% on contract manufacturer PCBA.
- Reduced warranty accrual requirement by 50%. Developed defect tracking for warranty products, validated post-warranty reject rate and validated
random component failures.
- Improved process efficiency by 200% for a critical component qualification process by reducing cycle time from 6 weeks to 2 weeks.
- Responsible for implementing, maintaining and quarterly reporting on the quality system compliance with ISO 9001.
- Developed customer specifications with OEM customers on requirements.
Senior Quality Engineer, medical device, ANDROS. (160 personnel) '93 to '95
- Reduced warranty backlog from $800K to $50K in 6 months, while reducing staff. Developed defect tracking for warranty products and validated
standard repair actions.
- Increased inspection acceptance rate from 85% to 97% for a critical motor component by implementing a calibrated sound chamber and correction
factor with factory.
- Conducted supplier relations; MRB, audits, CLCA, qualification, inspection planning
- Developed OEM customer specifications for the design of breath analysis product in support of customer’s submission strategy.
- Improved preparation for FDA inspection, through training of personnel on the QSR (GMP), ISO 9001, and FDA.
EDUCATION:
- BS in Electronic Engineering Technology, DeVry Institute of Technology, Phoenix, AZ
- JIT Certification, JIT Institute of Technology, Denver, CO.
- Varian Microwave Equipment Division Certified Instructor, Quality Improvement Process.
- ASQC Continuing Education; QSIT Training, ISO 13485:2003, ISO 9001:2000, Process Analysis
AFFILIATIONS:
- Regulatory Affairs Professional Society (RAPS)
- American Society for Quality (ASQ) - Biomedical Division
- American Society for Quality (ASQ), Silicon Valley Chapter
- Institute of Industrial Engineers (IIE)
- Alliance of Technology and Women (ATW)
- Second Harvest food bank, volunteer
- Institute of Electrical and Electronic Engineers (IEEE)
- BioDevice Group organization (BDG)
- ProMatch, non-profit, trainer with 70+ contact hours
- PenPro, non-profit, trainer with 50+ contact hours
CLEARANCE:
- SECRET clearance at Varian Microwave Equipment Division (DBA CPI)
- SECRET clearance at Litton Electron Devices (DBA L3)
|
