SUMMARY

• Leadership and management in Quality System and multi - complex projects
• Commissioning and Qualification (C&Q) Program (wif Risk-Based and Science-Based) Implementation
• Process analytical technology (PAT) development and implementation for teh biological manufacturing process
• Quality system and manufacturing processes improvements
• Coach and train teh use of Lean Six Sigma Tools as well as Quality System

COMPETENCIES

• Six Sigma Black Belt Certification
• C&Q Lifecycle & Risk-Based Approach
• Project Management and Leadership
• QE Tools such as FMEA, FTA, VSM etc.
• Quality System and Operation Improvement
• Statistical Analysis and Design of Experiment
• Method and Technology Transfer
• CAPA, Risk Management, Change Management

PROFESSIONAL EXPERIENCE

Confidential

Quality Engineer Manager

Responsibilities:

• Lead Quality Engineers to provide quality support in design, development, and change to medical device, assay, and software products as well as QA associate to support day-to-day activity.
• Partner wif R&D and Manufacturing to introduce Quality by Design concept into teh product and process.
• Coach and guide Quality team to set annual goals/objectives and enhance career development.
• Manage and lead projects such as QS process improvement (Product Complaints, Change Control etc), Software Validation (MasterControl, eClinical OS, EPDM), Software Life Cycle and Continued Process Monitoring.
• Oversee teh design and development (D&D) as well as product life cycle processes for new and existing devices and software to ensure quality compliance are fulfilled wif respect to Design Control.
• Facilitate and coach teh risk management activities/files during D&D and lifecycle of product per ISO14971.
• Oversee and coach design, process and software validation and equipment qualification to ensure quality requirements and apply risk-based approach per ISO14971 and IEC62304.
• Provide quality oversight to CMOs to ensure cGMP compliance of operation.
• Develop and manage quality system metrics reporting to senior management to promote visibility to teh organization and initiate continuous improvement.
• Manage CAPA, Deviation, and Nonconformance processes.
• Review and approve all validation and technical documents, CAPA, Deviations and Nonconformances.
• Plan, conduct and report internal and external audits and support audit readiness for FDA and Notified Body inspections.
• Author technical documents such as VMP, Validation Plan/Protocols, Commissioning and Qualification Plan/Protocols, Risk Management and other technical documents.
• Conduct Quality System and EQMS Trainings.

Confidential, Phoenix, AZ

Senior Validation Engineer

Responsibilities:

• Led teh validation group to coordinate commissioning, qualification and validation activities, and coordinate resources wif Production, Engineering, Planning, and QC departments to ensure efficient and timely completion of teh projects.
• Designed, developed and implemented Commissioning & Qualification (C&Q) process wif risk-based and science-based approaches.
• Authored and executed commissioning, qualification, and process validation for solid dosage and capsule manufacturing and packaging processes, equipment and utilities including HVAC, USP Purified Water System etc.
• Developed validation master plans and revalidation strategies.
• Designed and implemented teh periodic manufacturing process monitoring and review strategy.
• Accomplished strategic planning and leadership for complex validation projects.
• Provided leadership and validation guidance via coaching, reviewing, and executing validation activities.
• Investigated failures and deviations related to C&Q and assisted wif corrective and preventive actions.
• Participated in internal audits and regulatory inspections including FDA, MHRA, ANVISA inspections.
• Mentored and trained process engineers on teh validation protocol generation and execution.
• Led teh cross-functional team for Batch Record improvement project using DMAIC to streamline teh process, reduced teh cycle time and redundancy works, resulting annual $250,000 saving.
• Provided technical support for QC incoming raw material sampling plan.
• Trained and coached Quality Department for use of Six Sigma and Lean Tools.
• Authored technical documents, SOPs, and policy documents.

Confidential, Seattle, WA

Quality Engineer

Responsibilities:

• Developed and implemented teh continuous process monitoring program (PAT) for biological manufacturing processes, applied statistical process control (SPC) and process capabilities to evaluate teh process performance and ensure teh product quality.
• Led Site Quality Engineers for continuous process monitoring program management and trend/ outlier analyses.
• Designed and developed risk- and science-based trend and outlier analyses for teh continuous process monitoring program applying FMEA.
• Facilitated Change Control process improvement project to streamline teh process to reduce teh cycle time and non- value added activities, resulting $150,000 cost avoidance.
• Facilitated teh product complaint and adverse event handling program improvement project by using DMAIC to streamline teh process, reduce teh cycle time, and redundancy works, resulting $900,000 cost avoidance.
• Managed teh cross-functional project to improve teh manufacturing sampling technique for QC testing by defining teh sampling technique and developing teh training program, resulting minimum $ 300,000 saving annually.
• Designed and developed protein release assay monitoring program applied SPC for QC.
• Tracked and trended metrics for management review.
• Authored technical reports, policy documents, and Annual Product Review.
• Executed development studies for commercial technical support and new product pipeline studies for IND submission.
• Performed root cause analyses for process deviations and nonconformance material and device/material failure investigations and provided or implemented corrective and preventive actions.
• Designed, developed, and executed first article inspections and qualification studies for device and raw materials.
• Designed and executed teh technology transfer for culture media and QC lab equipment.
• Design and developed devices to improve teh aseptic process technique in manufacturing process.
• Led and completed successfully teh new device implementation project wif a cross functional team.
• Authored SOPs and technical scientific reports.

Confidential, Vancouver, WA

Process Engineers

Responsibilities:

• Managed two technicians and one facility engineer.
• Improved process equipment performance and reduced manufacturing process waste to increase teh manufacturing capacity by three folds.
• Reduced teh changeover time by 50 percent as developing teh streamline, resulting $150,000 saving annually.
• Managed and completed successfully teh manufacturing scale-up and capital investment projects wif a cross-functional team.
• Authored and executed FAT/SAT protocols, Commissioning and Qualification protocols (IQ/OQ/PQ) for FSE.
• Executed teh FAT/SAT, commissioning, and qualification.
• Investigated nonconformance product issues and process deviations, identified teh root cause, and implemented corrective and preventive actions.
• Negotiated and completed teh procurement process for new process equipment.
• Developed, implemented, and executed training program for manufacturing group on new and existing equipment.
• Utilized teh statistical analysis to optimize teh filling and capping machine and reduce teh variation by 30 percent.