SUMMARY:

• 15+ years of diverse experience in Quality System Management, Quality and Regulatory Compliance, Design Controls, Verification and Validation, Software & Instrument, Computer System Validation for a wide range of medical devices, pharmaceutical, and biotechnology products
• Hands - on expertise in regulated environments: ISO 13485: 2003 Medical Device Quality Management System Requirements, FDA 21 CFR Part 820 Quality System Regulations, FDA CFR Part 11 Electronic Records Electronic Signatures, EN ISO 14971:2012 Risk Management, IEC 62304 Medical Device Software - Software Life Cycle Processes, IEC 60601 Medical Electrical Equipment, IEC 62366-1:2015, Medical Devices - Application of Usability Engineering to Medical Devices, Medical Device Directive (MDD), CGMP, GAMP5, IVDD 98/79/EC, GHTF, ICH, EU, CMS CLIA/CAP, PIC/S, TQM, SOX, SEI CMM, IEEE, IEC/EN/AAMI, MDD 93/42/EEC, ERP (SAP, Microsoft Dynamics, Oracle E-Business Suite), CE mark, FDA 510(k) submission
• In-depth knowledge and experience in Class II and III Manufacturing, Industrial Engineering, Process Engineering, Quality Engineering, Packaging Engineering, Supplier Controls, NCR (Non-Conformance Reporting), Lean, Six Sigma, Process Validation/Process Capability, Design Controls, Risk Management, Root Cause Analysis, Change Controls, Supplier Controls, FMEA, CAPA, Labeling, Packaging, Medical Device Reports (MDRs), Adverse Drug Events (ADE's), Complaint Handling and Reporting, CCB (Change Control Board) and MRB (Material Review Board). DHF, DHR and DMR development and maintenance
• Proven record of hands-on leadership and guidance across the wide range of Medical Devices, Pharmaceutical and Biotechnology products as well as exceptional skills in building a quality team, project management, planning and on time completion of tasks, with strong hands-on technical capability.

PROFESSIONAL EXPERIENCE:

Confidential, Redwood City, CA

Quality Compliance / Quality Systems Management / Design Control

• Leading quality activities for Guardant360 comprehensive liquid biopsy non-invasive tool for accessing and sequencing tumor DNA in compliance with internal quality requirements and regulatory standards: ISO 13485, FDA 21 CFR 820, FDA 21 CFR 11, ISO 14971, IEC 62304, CLIA, CAP and IVD.
• Providing Quality Assurance oversight of GxP software and instrument quality and validation that includes but is not limited to Infrastructure QA approvals of requirement specifications, IQ, OQ, PQ and system specific procedures related to IT-owned systems and the enforcement of applicable SOPs.
• Ensuring design control and software/systems development guidance to Personalized Health Care software development teams and life cycle teams and be the single point representative for Design Quality Assurance activities.
• Supporting IT Quality Records team (IT-QRT) in handling changes, deviations and CAPA management that includes tracking and documenting change management (CM) records, deviations, CAPA and other project team deliverables to ensure compliance to regulatory and client requirements.
• Ensuring change control and deviation investigation systems are under control performing the needed follow up with technical team, validation team, CM Leads for approvals and updating respective problem records (PR) in MasterControl EQMS.
• Leading compliance initiatives to support company policies, GxP requirements, product/internal IT controls related to 21 CFR Part 11, Annex 11, health care industry standards/best practices to increase efficiency and meet compliance requirements, and customers highest quality services.
• Maintaining current knowledge of the regulatory environment and requirements regarding GMP Quality Systems in the pharmaceutical/medical device industry. Continuously ensuring Quality System processes incorporating updated information and industry learning trends.
• Developing and implementing Customer Complaint and Corrective Action/Preventive Action (CAPA) systems to integrate recording of all customer complaints with use of CAPA system for those warranting action.
• Coordinating logistics for onsite audits for Regulatory bodies and Pharma partners scheduling and coordinating SMEs, preparing documentation, liaison between auditors and SME’s, audit tracking, trending audit findings and initiate process improvement activities.
• Serving as QA representative in risk management (EN ISO 14971) activities participating in cross functional team efforts in planning, analyses (FMEA, FTA, Risk/Benefit) and mitigations ensuring risk management files are adequately created and maintained.

Confidential

Quality Compliance / Design Control / Validation Specialist

• Leading Quality Compliance for new and existing GxP systems, IT infrastructure, servers, process equipment and information systems per current Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), FDA, ICH and other regulatory requirements.
• Providing design control and software/systems development guidance to Confidential mass spectrometry software development teams to be the single point representative for Design Quality Assurance activities.
• Reviewing and approving customer requirements, product requirements, design and development plans and reports, IQ, OQ, PQ, Verification and Validation plans and reports, design transfer documents, labeling, risk management plans and reports, project plans and SOPs.
• S upporting development and implementation of Quality Management System (QMS) and infrastructure / tools in compliance with FDA QSR, ISO (13485, 62304, 14971), and corporate policies.
• Leading the activities on Change Management, Supplier Qualification, Inspection, CAPA Management, Laboratory Procedures (GLP) and Supplier Auditing programs.
• Working with Quality team addressing CAPAs, Deviations and carry out Quality Investigation and root causes of any issues of non-conformances.
• Authoring qualification SOPs, procedures and instructions to enable compliance with GxP regulations to support business processes for proper qualification and validation of the systems.
• Analyzing business needs to be solved with IT systems and processes used in a GxP environment collaborating with business, quality, and technical individuals to ensure that applications and systems are in compliance with regulatory requirements.
• Conveying information from meetings and other communications to Quality Management to inform management of critical issues and to assure consistent feedback to teams which is in alignment with Quality Management policy.
• Authoring, review and approving Quality Plan and Report at milestones DI, DO and LD. Assist management in assessment of whether project has met requirements to pass milestone.
• Applying GAMP 5 risk based approach to determine the scope of validation for GxP systems to develop documentation and validation with appropriate justification of the approach.
• Performing FDA 21 CFR Part 11, 820, 210, 211 and EU Annex 11 Gap Assessments to ensure business processes are improved and efficiency increased while creating GxP compliant systems.
• Participated in Change Control Board (CCB), reviewing proposed change control, assisting in the validation impact assessment regarding to the changes, generating testing to ensure and document that GxP systems are maintained in the validated state in production.

Confidential, Foster City, CA

Quality Compliance Lead

• Performed QA compliance activities to support company's Quality Management System to ensure compliance of quality/business systems with FDA 21 CFR Part 11, 820, 210, 211, EU Annex 11, GAMP5 and other quality and regulatory standards and corporate policies.
• Provided design control and software/systems development guidance to Personalized Health Care software development teams and life cycle teams and be the single point representative for Design Quality Assurance activities on PHC software development project teams
• Supported QA compliance of validation activities for enterprise-wide GXP computer systems reviewing and approving validation and qualification deliverables, system documentation and business SOPs.
• Represented Quality Policies and Systems in Validation, Change Control, Discrepancy/Deviation, CAPA, Auditing and Enterprise Resource Planning (ERP) cross functional project enhancement meetings.
• Developed and implementing a risk-based approach to assessing need for electronic systems Vendor Audits as well as conducting vendor audits of software suppliers and service providers.
• Served as QA representative in risk management (EN ISO 14971) activities participating in cross functional team efforts in planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations ensuring risk management files are adequately created and maintained.
• Supported Training System Processing documents in Learning Management System (e.g. completed learning assignments, updated learning plans, etc.) for SAP Success Factors and Compliance Wire.
• Participated in development of 510(k) pre-marketing notification (PMN) and pre-market approval (PMA) to FDA submission providing reasonable assurance the device is safe and effective for its intended use.
• Implemented Post Market Vigilance to review, evaluate, and investigate product complaints relative to the identity, quality, safety, and effectiveness of Gilead products.
• Reviewed and assisted with necessary Engineering Protocols, Engineering Test Reports and other design documents necessary to ensure that products are verified and transferred to production.

Confidential, Concord, CA

Senior Quality Engineer

• Performed Quality Assurance of design and product development process of Confidential Liberty Cycler Automated Peritoneal Dialysis and Hemodialysis Delivery Systems to ensure compliance of quality/business systems to requirements and procedures.
• Reviewed and approved documentation consistent with design control regulations and guidance's dealing with systems/software development, verification and validation practices and GPS design control policy and SOPs.
• Developed new process qualification and validation for Liberty Cycler Automated Peritoneal Dialysis manufacturing that included process improvement, IQ, OQ, PQ, process validation, risk assessment, FMEA, and GMP commercial implantation.
• Documentation to include but not limited to DHF documents such as customer requirements, product requirements, design and development plans and reports, verification and validation plans and reports, design transfer documents, labeling, risk management plans and reports, project plans and milestone documentation.
• Established and promoted the work environment to support Quality Policy and Quality System Management Requirements assessing and monitoring the status of FDA, MDD, and ISO compliance.
• Ensured that requirements and specifications are captured adequately in verification, validation, and relevant qualification studies to comply with FDA 21 CFR 820, ISO 13485:2003, CMDR SOR 98/282, EU Medical Device Directive 93/42 establishing QMS compliance.
• Worked with R&D, Regulatory, Medical, Manufacturing and Legal to design products and processes, develop risk analysis related to design controls defined by 62304 Medical Device Software Lifecycle, ISO 14971 Risk Management and IEC 60601 Medical Electrical Equipment.
• Reviewed and assisting with necessary Engineering Protocols, Engineering Test Reports and other design documents necessary to ensure that products are verified and transferred to manufacturing appropriately.
• Supported Training System Processing training documents in Learning Management System (e.g. completed learning assignments, updated learning plans, etc.) for SAP Success Factors and Compliance Wire.
• Maintained complaints in Compliant Management Database. Assigning complaint class based on master symptom code severity list. Ensuring complaint responses, reply to complaint is documented when applicable and ensure timely closure of all complaint files.
• Tracking and trending compliance activities on a periodic basis preparing CAPA and IACA (Internal Audit Corrective Action) metrics and generating reports for management reviews.
• Participated in cross-divisional activities to integrate quality system information and assist the stakeholders to receive a timely feedback on open corrective actions.
• Served as QA lead in complex quality investigations/deviations/clinical complaints, represent QA on Materials Review Boards, and independently author or approve concise quality investigation reports with appropriate corrective action and preventive actions (CAPA).
• Led external audit activities (FDA, FDB, ISO registrar audits) and internal audits of quality systems to ensure compliance to appropriate standards and guidance documents.
• Prepared the identification and statistical analysis of performance metrics to support Investigations associated with Product Failures, Product Complaints, and Product Actions.

Confidential,Foster City, CA

Lead Quality Compliance & Validation Engineer

• Led QA Compliance activities to execute quality and regulatory functions in the organization to ensure compliance of the quality/business systems to applicable regulations, standards, and corporate policies.
• Maintained programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
• Reviewed routine manufacturing, environmental monitoring, and quality control data for in-process and finished products.
• Supported tracking and trending compliance activities on a periodic basis preparing CAPA and IACA (Internal Audit Corrective Action) metrics and generating reports for management reviews.
• Participated in cross divisional activities to integrate quality system information and assist the stakeholders to receive a timely feedback on open corrective actions.
• Served as QA lead in complex quality investigations/deviations/clinical complaints, represent QA on Materials Review Boards, and independently author or approve concise quality investigation reports with appropriate corrective action and preventive actions (CAPA).
• Led external audit activities (FDA, FDB, ISO registrar audits) and internal Confidential audits of quality systems to ensure compliance to appropriate standards and guidance documents.
• Supported creation of Risk Management Files including Design/Use FMEA with relevant cross functional teams in u tilizing Quality Engineering tools (FMEA and Process Mapping) for Incident Management.
• Prepared the identification and statistical analysis of performance metrics to support Investigations associated with Product Failures, Product Complaints, and Product Actions.
• Provided QA oversight and assessment for GxP computer systems related deviations, CAPA and change controls to apply risk based methodology to validation efforts.

Confidential, Palo Alto CA

Quality System Management Specialist

• Provided Quality Engineering input to support new product development and R&D activities establishing quality engineering methodologies, systems, and practices to meet corporate goals, customer, and regulatory requirements.
• Conducting activities to ensure that the Design control process is in compliance with applicable standards and regulations, including FDA QSR, GXP, ISO 9001, EN 46001, and MDD.
• Identified and implemented effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
• Participated in the implementation of assurances, Design Controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Utilized FDA CFR Parts 820, 11 and Annex 13 Gap assessments developing and executing remediation plans for IT infrastructure to assure that the business process is improved and efficiency increased while creating GXP compliant computerized systems.
• Prepared and executed investigational and instrumentation characterization protocols for selected analytical test equipment, analyzing multivariate results, and preparing summary reports.
• Co-authored SOPs for Change Controls, SDLC, and Excel validation and maintenance requirements.
• Performed validation of Excel spreadsheets used for analytical laboratory calculations in Electronic Lab Notebook (ELN).
• Ensured GMP SOP revision and approval process including working with various stakeholders to identify required content, address any questions and comments, and shepherd the final document through the formal electronic approval process in Pharmadoc.
• Responsible for assessing QC validated analytical instrument/software and remediation of the gaps with focus on 21 CFR, Part 11.
• Assured that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the corporate Quality Policy.

Confidential, Hayward CA

Lead Quality Engineer, Software and Instrument

• Planned and conducted activities concerned with the quality assurance of industrial processes and materials on OptiScanner, an automated, plasma-based bedside monitoring system intended to assist healthcare providers manage the glucose level of critically ill patients within an optimum target range.
• Performed quality control and design V&V of OptiScanner IVD to ensure it complies with the design control requirements of FDA 21 CFR Part 820.30, ISO 13485, MDD 93/42/EEC and IVDD 98/79/EC.
• Participated in development of 510(k) pre-marketing notification (PMN) and pre-market approval (PMA) to FDA submission to provide reasonable assurance that the device is safe and effective for its intended use.
• Developed and implemented appropriate test plans, risk analyses, FMEA for ensuring a safe, and effective product design.
• Ensured product design test sampling plans are adequately supported with the appropriate scientific rationale and justification.
• Reviewed and approved changes to raw material, assembly and final product specification changes and ensure revisions are implemented in a controlled and staged manner.
• Initiated the activities that may lead to product failure investigations. Ensure such investigations are adequately documented per applicable procedures.
• Applied the appropriate statistical method when analyzing data to evaluate the current process, trending and publishing the data to assure that CAPAs are addressed and closed in a timely manner.
• Administered NCR database, chairing MRB to process nonconforming materials for a disposition working closely with purchasing and engineering to select appropriate suppliers.
• Performed periodic supplier audits to assure product quality standards are met. As appropriate ensure the approved supplier list is updated.
• Designed and implemented methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and/or production equipment. Ensures all equipment and tooling used to manufacture, assemble, or test product or components has been validated.

Confidential, Abbott Diabetes Care, Alameda CA

Sr. Quality Compliance Engineer

• Provided Quality engineering support to manufacturing and product development teams to ensure delivery of highest quality for of Abbott Diabetes Care Insulinx glucose meter that provides treatment recommendations to reduce the patients overall glucose to maintain a low risk of hypoglycemia.
• Ensured that adequate product test plans are developed and executed in accordance to internal and external design control requirements for IVD products (21 CFR 820.30, ISO 13485, GMP, IEC, ANSI, and other applicable standards).
• Assured that requirements and specification are captured adequately in verification, validation, and relevant qualification studies.
• Developed and implemented Customer Complaint and Corrective Action/Preventive Action (CAPA) systems in tandem to integrate recording of all customer complaints with use of CAPA system for those warranting action.
• Participated in implementation of effective process control systems to support the development, qualification, and on-going manufacturing of products to meet internal and external requirements.
• Identified and acquired necessary internal and external resources and teams to support intended product development/distribution plans resulting in regulatory submissions and compliance requirements.
• Performed audits of raw material vendors and prepared manufacturing documentation for updated filing.
• Led internal audits of quality systems to ensure compliance to appropriate standards and guidance documents.
• Successfully completed of new process qualification and validation for meter strip manufacturing that included process improvement, IQ, OQ, PQ, process validation, risk assessment, FMEA, and GMP commercial implantation.
• Reviewed testing, quality control and other testing reports for accuracy, completeness, and compliance to requirements to ensure that quality assurance standards and regulatory requirements are met.

Confidential, Palo Alto CA

Principal Quality Systems Engineer

• Performed Quality Systems Engineering for production of Confidential medical devices for radiotherapy treatments in compliance with FDA QSR design control requirements 21 CFR Part 820.30, 21 CFR Part 11, IEC 62304 Software Life Cycle Processes, ISO 13485 Quality Standard.
• Developed and maintained quality engineering methodologies, systems, and practices to meet corporate, customer, and regulatory requirements and to improve awareness, visibility and communication on quality initiatives.
• Participated in development of 510(k) pre-marketing notification (PMN) and pre-market approval (PMA) to FDA submission to provide reasonable assurance that the device is safe and effective for its intended use.
• Ensured requirements and specifications are captured adequately in verification, validation, and relevant qualification studies.
• Worked with project members to develop design verification and validation plans, protocols and served as an approving authority in the QA department for such reports.
• Performed a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting audits, managing training programs, performing data and documentation reviews and analysis.
• Developed and implemented Customer Complaint and Corrective Action/Preventive Action (CAPA) systems to integrate recording of all customer complaints with use of CAPA system for those warranting action.
• Supported internal audit program, including planning and performing audit activities, ensuring timely performance of scheduled audits, and issuance of reports and findings.
• Developed and implemented product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses, FMEA.
• Supported the development and execution of streamlined business systems which effectively identify and resolve quality issues.
• Contributed to the development of company's quality system policies and procedures to achieve objectives in creative and effective way.

Confidential,Davis, CA

Staff Quality Engineer

• Performed Quality Engineering for Schilling Robotics remotely operated equipment for subsea environments under ISO and GxP standards and regulations.
• Products include electric and hydraulic world-class remotely operated vehicles (ROVs), tether management systems (TMS), remote manipulator systems, and modular control systems for wide-ranging sub-sea applications.
• Authored, reviewed, and executed manufacturing validation protocols, reports, and plans to assure FDA CFR 21 Part 820 compliance.
• Daily tasks primarily target software validation of manufacturing processes (IQ/OQ/PQ) and device firmware. Worked within teams to meet manufacturing and R&D milestones.
• Responsible for planning and performing the audit activities. Implemented and conducted internal audit programs
• Logged and tracked to closure audit findings from internal audit and compliance audit programs.
• Developed, deployed and provided ongoing oversight of Corrective Action-Preventative Action (CAPA) system in compliance with 21CFR820.100 (QSR).
• Developed and implemented product quality plans, documentation, methods and procedures by creating product specifications, quality specifications, quality plans, and risk analyses.
• Maintained a working knowledge of government and industry quality assurance codes and standards (UL, IEC, ANSI, FDA, and ISO).
• Prepared and analyzed NCR for a disposition of nonconforming product and manufacturing process defect data.
• Gathered quality metric data and performing the appropriate analysis methods to secure product design and new product development.

Confidential,Milpitas, CA

Senior Quality Engineer

• Performed Quality Control and Validation of medical devices, VISX WaveScan and STAR Excimer Laser Systems that calculate the desired laser vision correction treatment of the human eye, and perform computer-controlled laser vision correction surgery under FDA standards and regulations.
• Primary responsibilities were Quality Control and Validation of product development process to ensure that the Design control process is in compliance with applicable standards and regulations including FDA QSR, ISO9001, EN46001, and Medical Device Directive.
• Authored, reviewed, and executed manufacturing validation protocols, reports, and plans to assure FDA CFR 21 Part 820 compliance. Reviewed design documents associated with manufacturing processes
• Daily tasks primarily targeted validation of manufacturing processes (IQ/OQ/PQ) and device firmware
• Involved in validating SAP R/3, EDMS, Oracle Siebel, Labware LIMS, Clinical Data Acquisition System and Web applications.
• Verification and validation of in-house Patient Information Management System (PIMS), an application that tracks all aspects of patient records such as: patient vital signs, medication, allergies, problems, doctor notes, consultations, and inter-office physician correspondence.
• Application uses 3-tier architecture comprised on user interface, middleware (i.e. data access objects) and database.
• Developed flowchart and wrote SOP of manufacturing defect tracking process to support regulatory requirements for SDLC test phase using Quality Center
• Responsible for planning and performing the audit activities. Implemented and conducted internal audit programs.
• Logged and tracked to closure audit findings from internal audit and compliance audit programs.
• Developed and conducted training and awareness on FDA QSR, ISO 13485, ISO 9001, and other medical device regulations, both domestic and international.