SUMMARY:

• Extensive years of experienced as Quality Engineer with Outstanding Communication skills
• Knowledge of Food and Drug Administration (FDA) Regulations, Medical Devices Directive (MDD), Canadian Medical Device Regulations (CMDR), Canadian Medical Devices Assessment System (CMDCAS), Quality System Requirements (QSRs) FDA 21 CFR Part 820, International Organization for Standardization (ISO) 9001, 13485, 14971 and 11607 Part I and Part II. Also,knowledge of IEC 02304, IEC 60601 - 1 Medical Electrical Equipment and collateral standards, IEC 62366 Usability, and IEC 62304 Software Lifecycle to product development projects.
• Knowledge of current Good Manufacturing Practices (cGMP), Processing, Packaging or holding of Drugs and Finished pharmaceuticals (FDA 21 CFR Parts 210 and Parts 211). Also, knowledge of Sarbanes-Oxley Law.
• Knowledge of Labeling and Packaging Control respectively (FDA 21 CFR Part 820.120 and Part 820.130)
• Knowledge of blueprint reading and geometric dimensioning and tolerancing, understanding of QSR/ISO regulations, design controls, design assurance, FMEA, and product testing methods, and are able to use optical comparators and CMM’s
• Support new product/line extension projects involving in risk analysis, master validation plans and transfer design to manufacturing. Wrote record retention Standard Operating Procedure.
• Apply Six Sigma and Lean Principles including Gage Repeatability and Reproducibility (Gage R&R), Failure Mode and Effects Analysis (FMEA), Process Capability Index (Cpk), Design of Experiments (DOE)
• Actively contribute to the data collection, trend analysis, investigation, Corrective and Preventive Action (CAPA), and improvements to processes, products and systems

TECHNICAL SKILLS:

Team: Leadership, Coaching & Motivating, Selling Ideas, Collaborative Problem Solving, Conducting Effective Meeting, Time Management, Effective presentation, Strategic Thinking, Keen listening, Contract Negotiation

Computer Skills: Strong Microsoft Office skills (Word, Excel, project, Access, Visio). Proficient in Minitab and AutoCAD.

PROFESSIONAL EXPERIENCE:Confidential

Quality Engineer

Responsibilities:

• Managed non-conformance and complaints handling investigations (that is conducted root cause analysis and disposition analysis, failure investigations)
• Coordinated the root cause analysis reporting of Non-Conforming Products, Customer Complaints and Return Good Authorizations. Participated in Material Review Board meetings
• Conducted complaint investigations and provided corrective and preventive actions based on sound engineering analysis and review. CAPA process.
• Actively contributed to the data collection, trend analysis, investigation and improvements to processes, products and systems
• Provided engineering expertise in the form of project identification, development, and management
• Managed projects by developing a project schedule, tracking costs, and preparing status reports

Confidential

Staff Quality Engineer

Responsibilities:

• Applied Six Sigma and Lean Principles including Gage R&R, FMEA, Cpk, DOE
• Actively contributed to the data collection, trend analysis, investigation and improvements to processes, products and systems
• Managed non-conformance investigations (that is conducted root cause analysis and disposition analysis, failure investigations)
• Coordinated the root cause analysis reporting of Non-Conforming Products, Customer Complaints and Return Good Authorizations. Participated in Material Review Board meetings
• Managed non-conformance and complaints handling investigations (that is conducted root cause analysis and disposition analysis, failure investigations)
• Coordinated the root cause analysis reporting of Non-Conforming Products, Customer Complaints and Return Good Authorizations. Participated in Material Review Board meetings
• Conducted complaint investigations and provided corrective and preventive actions based on sound engineering analysis and review. CAPA process.
• Developed systems for the identification, analysis, correction, and prevention of quality issues
• Conducted complaint investigations and provided corrective and preventive actions based on sound engineering analysis and review. CAPA process.
• Assured compliance to in-house and/or external specifications to standards, such as GMP/GDP, medical Devices and ISO 13485 regulations, and approved disposition for non-conformances on raw materials and finished goods. Analyzed production quality data, identify trends and work with functional managers for preventive actions
• Experience in quality system audits with the suppliers
• Conducted Risk Management activities including FMEA, Process Validation including IQ/OQ/PQ/) to assure new products meet guidelines (ISO 14971, FDA, MDD, CMDR and CMDCAS)
• Exercised judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. The results (reduced costs, improved quality, effective corrective action, reduced cycled times and process capability) delivers were satisfactory.

Confidential

Quality Engineer

Responsibilities:

• Perform internal and external audits with the suppliers and vendors
• Negotiating contracts with the suppliers and vendors
• Managed non-conformance and complaints handling investigations (that is conducted root cause analysis and disposition analysis, failure investigations)
• Coordinated the root cause analysis reporting of Non-Conforming Products, Customer Complaints and Return Good Authorizations. Participated in Material Review Board meeting
• Conducted complaint investigations and provided corrective and preventive actions based on sound engineering analysis and review. CAPA process.
• Apply Six Sigma and Lean Principles including Gage R&R, FMEA, Cpk, and DOE
• Actively contribute to the data collection, trend analysis, investigation and improvements to processes, products and systems
• Conduct Risk Management activities including DFMEA/PFMEA, Process Validation including (IQ/PQ/OQ/) to assure new products meet guidelines
• Knowledge of blueprint reading and geometric dimensioning and tolerancing, understanding of QSR/ISO regulations, design control, design assurance, FMEA, and product testing methods, and are able to use optical comparators and CMM’s
• Perform training on label configuration, label control, software validation, document control, and bar coding. Perform internal audit on label and packaging standard operating procedures
• Reviewed and completed the following design assurance documentation for combination devices/Products
• Write and execute measurement/inspection systems equipment Validations including Computerized Software Validation (CSV)
• Evaluate and review software during the ongoing development of the device design. Authorize engineering development documents and design history files (DHF)
• Managed non-conformance investigations (that is conducted root cause analysis and disposition analysis, failure investigations)
• Apply design control principles according to FDA 21 CFR Part 820.30 to combination drug medical devices products. Establish a properly document design control system (design history file) for each device
• Wrote design plan and participate in design review to confirm design outputs conform to design input
• Develop and validate test methods and conduct measurement system error studies by using Gage R & R
• The results (reduce costs, eliminate non-value added work, improve quality, effective corrective action, reduce cycle times and process capability) delivers were satisfactory.

Confidential

Quality Assurance Manager

Responsibilities:

• Performed risk analysis and evaluation on combination devices/products. Identified the design and process change logs and check for possible gaps analysis in documentation
• Managed non-conformance and complaints handling investigations (that is conducted root cause analysis and disposition analysis, failure investigations)
• Coordinated the root cause analysis reporting of Non-Conforming Products, Customer Complaints and Return Good Authorizations. Participated in Material Review Board meetings
• Conducted complaint investigations and provided corrective and preventive actions based on sound engineering analysis and review. CAPA process.
• Perform internal and external audits with the suppliers and vendors
• Negotiating contracts with the suppliers and vendors
• Worked on FMEA’s, Control plans, (ISO 14971, FDA, MDD, CMDR and CMDCAS). Supervisory experience -training, coaching, mentoring, leading, motivating and championing Quality Engineers.
• Trained packaging inspectors on the work instructions
• Performed internal audit with the suppliers to ensure that packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling and distribution
• Involved with label configuration, label control, software validation, document control, and bar coding
• Applied design control principles according to FDA 21 CFR Part 820.30 to class II and class III medical devices. Established a properly document design control system (design history file) for each device.
• Wrote design plan and participated in design review to confirm design outputs conform to design input.
• Evaluated the company’s pre-production QMS using internal audits.
• Established the lifespan or shelf life of sterile medical device packages using accelerated aging according to ASTM F1980
• Coordinated the root cause analysis reporting of Non-Conforming Products, Customer Complaints and Return Good Authorizations. Participated in Material Review Board meetings
• Developed systems for the identification, analysis, correction, and prevention of quality issues
• Conducted complaint investigations and provided corrective and preventive actions based on sound engineering analysis and review. CAPA process. Preformed engineering design of experiment (DOE)
• Conducted feasibility studies on projects
• Conducted Risk Management activities including FMEA (Failure Mode and Effect Analysis), Process Validation (IQ/OQ/PQ) to assure new products meet guidelines
• Performed equipment and process validations, process monitoring and controls
• Hands-on experience on applied statistics, Lean Manufacturing, 5S, Six Sigma concepts, JIT
• Worked with the manufacturing, sales / marketing, R&D to coordinate pilot production of new process validations and risk analysis (FMEA)
• Supported new product/line extension projects involving risk analysis, master validation plan and transfer design to manufacturing
• Knowledge of 21 CFR Parts 820, FDA Quality System Requirements (QSRs), and ISO 9001 and ISO 13485.The results (reduced costs, eliminated non-value added work, improved quality, effective corrective action, reduced cycled times and process capability) delivers were satisfactory.

Confidential, CA

QA specialist

Responsibilities:

• Analyzed, reviewed and audited manufacturing batch records according to FDA 21 CFR Parts 210 and 211 cGMP Manufacturing, Processing, Packaging or Holding of Drugs and Finished Pharmaceutical
• Monitored manufacturing processes, products and material to ensure all process are operating within defined standards
• Perform internal and external audits with the suppliers and vendors
• Negotiating contracts with the suppliers and vendors

Confidential, Greater Los Angeles Area, CA

Quality Engineer

Responsibilities:

• Managed non-conformance and complaints handling investigations (that is conducted root cause analysis and disposition analysis, failure investigations)
• Coordinated the root cause analysis reporting of Non-Conforming Products, Customer Complaints and Return Good Authorizations. Participated in Material Review Board meetings
• Conducted complaint investigations and provided corrective and preventive actions based on sound engineering analysis and review. CAPA process.
• Applied Six Sigma and Lean Principles including Gage R&R, FMEA, Cpk, DOE
• Actively contributed to the data collection, trend analysis, investigation and improvements to processes, products and systems
• Assured compliance to in-house and/or external specifications to standards, such as GMP/GDP, medical Devices and ISO 13485 regulations, and approved disposition for non-conformances on raw materials and finished goods. Analyzed production quality data, identify trends and work with functional managers for preventive actions
• Experience in quality system audits with the suppliers
• Conducted Risk Management activities including FMEA, Process Validation including IQ/OQ/PQ/) to assure new products meet guidelines (ISO 14971, FDA, MDD, CMDR and CMDCAS)
• Exercised judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. The results (reduced costs, improved quality, effective corrective action, reduced cycled times and process capability) delivers were satisfactory.

Confidential, Great Los Angeles Area, CA

Assistant Project Engineering Intern

Responsibilities:

• Provided engineering expertise in the form of project identification, development, and management
• Managed projects by developing a project schedule, tracking costs, and preparing status reports
• Performed equipment sizing based on specifications. Generated PFD and P&ID
• Prepared and presented technical report to management
• Conducted team meeting on projects with staff from quality, R&D, and Manufacturing
• Communicated issues and progress of projects to management
• Preformed engineering design of experiment (DOE)
• Conducted feasibility studies on projects
• Designed and implemented manufacturing processes and equipment from pilot to fully operational. Used Microsoft project to track projects
• Researched, developed and prepared specifications for new products, processes, equipments, and technology. Conducted field investigations to check performance or conformity to plans and specifications
• Prepared, maintained and reported statistical, technical or analytical engineering data. Used statistical analysis, failure mode analysis and risk analysis on data to comply with FDA regulations
• Trained and supervised production staff to conduct engineering tests according to the engineering test plan
• Interfaced with quality assurance, product, and manufacturing and R&D managers to sell several projects. The results (reduced costs, improved quality, effective corrective action, reduced cycled times and process capability) delivers were satisfactory.