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Skills
- Non-Conformance Reduction
- Product lifecycle management
- ISO 9001:2015 Quality Management Systems
- Root cause analysis (RCA)
- Report Writing
- Supplier Quality Performance Monitoring
- Document control
- Project Management in Quality Systems
- Process optimization
- Customer complaint resolution
Work Experiences
- Investigated non-conforming products.
- Reduced cycle time by [Percentage]%.
- Conducted comprehensive process capability studies.
- Resolved complaints within [Number] days.
- Supervised implementation of automated data collection systems.
- Responded to regulatory risk assessments.
- Implemented real-time Quality Management Software.
- Achieved a [Number]% decrease in internal quality non-conformances.
- Introduced Lean Six Sigma methodologies, leading a team in reducing non-value-added processes, achieving a [Amount] savings in [Year].
- Reduced regulatory issues by [Percentage].
Summaries
- Implemented effective risk management strategies.
- Improved compliance.
- Achieved a [Number]% reduction of waste.
- Enhanced product consistency.
- Actively analyzed returns.
- Delivered comprehensive quality system training programs.
- Streamlined change control procedures.
- Implemented proactive quality management.
- Implemented automation solutions for seamless data collection, reducing margin for error by [Percentage] while improving decision-making accuracy.
- Drove corrective actions.
Accomplishments
- Utilized statistical process control (SPC) to monitor production variances, leading to [Number]% improvements in process consistency.
- Developed validation protocols for critical equipment, achieving 100% compliance during FDA inspections with zero observations.
- Managed the calibration and validation documentation for [Equipment], ensuring adherence to industry compliance standards and avoiding regulatory penalties.
- Collaborated in cross-functional teams to design and roll out product quality improvement plans, reducing defect rates by [Percentage]% within [Time period].
- Led project-specific quality reviews that minimized downtime and process disruptions, resulting in an [Number]% increase in operational efficiency.
- Led root cause and corrective action (RCCA) reviews for critical deviations, reducing them by [Percentage]% within [Time period].
- Developed cross-functional relationships with R&D and manufacturing to improve process verification steps, achieving a [Number]% success rate in initial production runs.
- Partnered with suppliers and internal teams on non-conformance management, reducing rejected components by [Number]% within [Time period].
- Implemented a continuous improvement initiative that generated a [Percentage]% improvement in First-Pass Yield (FPY) for the [Product] division.
- Deployed risk management strategies for product launches, proactively reducing time-to-market by [Number]%.
Affiliations
- National Association of Manufacturers (NAM)
- Association for the Advancement of Medical Instrumentation (AAMI)
- Quality and Productivity Research Conference (QPRC)
- Biomedical Engineering Society (BMES)
- Society of Quality Assurance (SQA)
- International Conference on Quality Control Circles (ICQCC)
- Institute of Quality Assurance (IQA)
- American Academy for Clinical Quality Management
- Global Association for Quality Management (GAQM)
- Association for Operations Management (APICS)
Certifications
- Certified Calibration Technician (CCT) [Organization/Year]
- Certified Pharmaceutical GMP Professional (CPGP) [Organization] - [Year]
- Statistical Process Control (SPC) Specialist – [Organization], [Year]
- ISO 9001:2015 Lead Auditor - [Organization/Year]
- Certified in Risk and Reliability Management – [Organization], [Year]
- Certified Professional in Regulatory Affairs (RAPS) – [Organization], [Year]
- Certified Metrology Technician – [Organization], [Year]
- ISO/IEC 17025 Lead Auditor – [Organization], [Year]
- Certified Quality Auditor (CQA) [Organization] - [Year]
- Certified Supplier Quality Professional (CSQP) – [Organization], [Year]
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