SUMMARY:

• Senior Project Manager with expertise in software implementation, testing, and quality assurance (Six Sigma Green Belt trained).
• Experienced in managing multiple full project lifecycles from business development to final delivery.
• Proven track record of leading large scale program management initiatives in IT and manufacturing organizations.
• Knowledge and experience in pharmaceutical and medical devices in conformance with Confidential guidelines, 21CFR Part 11, Part 210 & 211, Part 820 Quality System Regulation, ISO 14971 and ISO 13485:2003 requirements
• Expert technical and analytical aptitude, skilled in a wide range of technologies.
• Expert in wide range of Software integration, validation and implementation, especially MES, and Quality systems.
• Excellent communications abilities, both written and verbal.

COMPUTER SKILLS:

General Software: Change Control Management, SAP Manufacturing Suite, MS Office, MS Project, and Visio

EXPERIENCE:

Confidential, Berkeley, CA

Project Lead

Responsibilities:

• Manage commissioning and qualification for new lab equipment and analytical instruments.
• Ensure all user requirements are met and adequate tests are documented in protocols.
• Write and conduct peer review and route protocols for review and approval process.
• Work with team to execute protocols, document punch list items and deviations.
• Manage deliverables and document completion dates as needed.

Confidential, Foster City, CA

Project Manager/Validation Engineer

Responsibilities:

• Participating in development of system validation plans to ensure that approach is commensurate with risk assessment
• Developing use cases and documentation of user requirements
• Leading development of functional requirements specifications to ensure that requirements are complete, accurate, and testable
• Developing test strategies and defining test data (i.e. design the approach for testing each requirement)
• Executing validation and verification testing protocols and documenting results
• Documenting and managing software defects and validation issues, assessments, and resolutions
• Authoring testing summaries and validation reports
• Preparing status reports for management

Confidential, Menlo Park, CA

Project Manager/QA Compliance Specialist

Responsibilities:

• Support the One AV integration project to conduct gap assessment for Process Validation, Design Validation and Equipment Controls.
• Support administration of Quality System processes (CAPAs, Internal Audits etc.).
• Assist the organization to receive timely feedback on open corrective actions.
• Participate in cross divisional activities to integrate quality system information.
• Conduct review and update Quality System procedures as necessary.
• Assist in developing & conducting Quality System training as necessary.
• Work on retrospective software validation projects to mitigate gaps in equipment validation as necessary.

Confidential, Sunnyvale, CA

Supplier Quality Engineer

Responsibilities:

• Worked on Supplier Qualification processes; with special reference to Gage R&R WI, to assure all Supplier Measurement tools have proven study for use and align to the results required by the Site procedures.
• Gathered data to find gaps for Process Validation reporting, to complete retrospective reporting if needed.
• Assure 100% compliance to ISI training for Suppliers.

Confidential, Redwood City, CA

Quality & Compliance Project Manager

Responsibilities:

• Facilitate PAI activities for the commercial release of product.
• Serve as the liaison to manufacturing, regulatory and commercial to integrate project requirements and deliverables related to QC testing, QA activities and CMO/ CTL deliverables.
• Work bi - directionally to inform Quality of changes to schedules and assist in evaluating impact and capability to manage change.
• Develop process maps for process optimization teams to define as-is models and improvement models along with specific targets for quality systems.
• Works with Quality to evaluate metrics and measurement strategies to support improvement efforts, trending and reporting of core activities within the Quality Organization.
• Conducts GMP training and collaborates with Document Control group for Employee training completion and update of training records
• Provide validation expertise to ongoing validation projects, conduct gap assessment for procedures and guidelines.

Confidential, Dublin, CA

Supplier Quality Engineer

Responsibilities:

• Report raw material non-conformances to Suppliers, and, work with buyers to assure that the current inventory supports the monthly plan /goal.
• Review the GD&T drawings to find the deficiency in the product on the floor, to assure proper communication to the Supplier for correcting their issue to provide acceptable product.
• Work on continuous improvement methodologies such as PDCA to be lean and green plant.
• Analyze the root cause of complaints and pareto the results to be able to derive 20% of defects that cause 80% of the problems.

Confidential, Plainsboro, NJ

Sr. Project Manager/Validation Engineer

Responsibilities:

• Restructure the Process Validation Policies, Procedures, and Work Instructions to be compliant with the QS Regulation, plus other stands and guidance documents.
• Review MVP, MVR and Equipment IQ/OQ/PQ reports and assess need for retrospective validation.
• Develop specification document, test methodologies, test plans and reports to ensure mfg. processes are validated to meet regulatory requirements.
• Utilize Quality Engineering skills and tools to optimize the Process Validation strategy, Sample Testing, Gage R&R studies, program and processes, as applicable using six sigma, project management, process mapping.
• Conduct technical assessment of Design History Files, Design Controls and Risk Management Files.

Confidential, Fremont, CA

Quality Engineer/Project Manager

Responsibilities:

• Support the final assembly, packaging and boxing lines for the manufacturing of Atlantis Imaging catheter line of products.
• Initiate Confidential for process, complaints and product issues, conduct investigations and risk assessment, and, disposition product. Escalate issues to Confidential as needed.
• Collaborate with cross functional teams for equipment validations, gage R&R and change requests. Participate in IQ, OQ and PQ change process review and approvals.
• Conduct statistical analysis using Minitab to demonstrate required process performance and capability.
• Analyze scrap and complaints data to reduce product defects and reduce scrap rate.
• Conduct weekly audit on the production floor, assuring Operators were trained for the tasks being performed. Write audit reports, and observations as issues were found. Communicate the findings to the person audited and Supervisors and take appropriate action as needed.
• Support audits from External and Internal audit agencies. Follow up on mitigation strategy and completion of such findings and observations for reporting internally and externally.
• Conduct weekly Quality Material Review meeting for disposition of non-conforming product.
• Provide monthly Quality metrics to ensure Complaints, SCARs, NCs, Audits and CAPAs are routinely monitored, formally reported to management review.
• Member of Confidential review board for validity and timeliness check.
• Manage MES, Lean and Equipment Validation projects; provide schedules and meeting minutes to keep team aligned to deadlines. Gather user requirements and use cases as required.

Confidential, Sunnyvale CA

Client Implementation Engineer

Responsibilities:

• Provisioning clients for content distribution thru carriers, using SQL, Linux and web based technologies.
• Testing on various carrier handsets to ensure correct provisioning.
• Maintaining accounts in Salesforce.com

Confidential, Sunnyvale, CA

Computer Sales Management Trainee

Responsibilities:

• Assist customers to make best decision based on need and in-store discounts.
• Answer phone inquiries about in-store product availability.
• Work as a team to drive sales and knowledge.
• Attend video conference training and apply learned principles in daily tasks.
• Run daily reports for price changes, rebates and inventory cycle counts.

Confidential, San Jose, CA

Technical Support Specialist

Responsibilities:

• Answer phone, email and chat inquiries from customers, escalated as necessary.
• Analyze solutions and deliver update to improve the quality of knowledgebase.
• Log all customer phone inquiries into call tracking system so that recurring problems can be analyzed, reported to product development and resolved.
• Achieve and maintain high levels of customer satisfaction.

Confidential, Sunnyvale, CA

Sr. Technical Support Engineer

Responsibilities:

• Responsible for taking customer phone calls to resolve technical problems.
• Help customer implement Resumix with Oracle and MS SQL databases.
• Document troubleshooting notes for resolution of known problems.
• Create key weekly and monthly departmental metrics for reporting purpose.
• Act as the QA liaison for new product release and setting up test servers.
• Managing key projects for escalation of product defects and enhancements.

Confidential, Sunnyvale, CA

Administration/Substitute Teacher

Responsibilities:

• Assistance with office procedures like answering the phones, scheduling appointments and guiding children appropriately.
• Substitute teaching in Confidential in Cupertino
• Taught Math, Science and PE in Middle School.