Quality Engineer

Wilda Ivette De Jesus Santiago

***** ***** ****** **,

Tomball, TX 77377

Telephone 540-***-****

ac1rpz@r.postjobfree.com

U.S. Citizen: Yes

Federal Employee: No

Security clearance: Yes

PROFESSIONAL PROFILE

A highly qualified Industrial Engineer with expertise in Quality Assurance with more than Seventeen years’ experience in the field. Experienced professional in Management, Quality Control and Compliance, CRO, Validation, Quality Engineering, and Quality by Design, Reliability Engineering, Program and Project Management. Six Sigma Black Belt certified. Have experience in process improvement, audits, cleaning and process validation, equipment qualification, cost analysis, technology transfer products and government services. Possess excellent communication and problem-solving skills. Possess knowledge of a wide range of engineering theories, concepts, principles, standards and methods, knowledge of Business Operations and Integrations. Possess strong knowledge in FDA, MCA, ISO, ICH and other regulatory requirements agencies.

QUALIFICATIONS

• Six Sigma Black Belt Certification • SPC

• Exceptional Communication skills • GMP, GLP and GXP

• Improve documents • Skill in methods of Communication

• Leadership skills • Innovative / creative problem solving

• Think logically • Project Management

• Cleaning CMI certified • Bilingual

• Continuous Improvement • Business Strategy

WORK EXPERIENCE

Senior Program / Project Manager June 2013- Sep 2016

SourceAmerica, Inc. Vienna, VA 22182

Oversee the contract performances of the Federal Supply Schedule. Perform administrative functions such as operations, planning, and personnel management. Provide expert advice in Quality Management Systems implementations, regulatory submissions and direction on manufacturing projects related to quality. Responsible for the building and driving effective teams by developing defined team member roles and responsibilities.

Duties

Lead and supervise activities related to FDA submissions where the Non-Profit Agencies have not experiences. (i.e. FDA, MCA, ICH regulations and procedures), including ISO 9000, 9001 and 13485 standards, MDD, IVDD and CMDR for medical devices.

Statistical analysis for production control scheduling to improve forecasting.

Propose and refine solution definitions to align stakeholder problem statements with strategic goals.

Evaluate risks, identify pitfalls and facilitate resolution, prioritize recommended actions, and identify significant activities, resources, and milestones.

Define program for implementation of selected solutions including roadmaps and funding strategies.

Manage program execution by delivering high quality outcomes within budget and on schedule.

Develop, improve, and drive streamlined project and program execution, documentation, information management, and business processes in department. Align department work processes to SourceAmerica business processes.

Represent department on cross-functional and corporate teams including OE and business process implementation.

Provide support during all FDA Establishment Registration, FDA Device Listings, FDA Certificates to Foreign Government.

Develop and implement effective communication plans. Drive information flow to stakeholders through regular reporting and communication.

QA/QC Manager Sep 2011 – June 2013

Didlake, Inc Manasas, VA 20110

Oversee the quality assurance of the contract performances. Perform administrative functions such as operations, planning, and personnel management. Provide expert advice and direction on quality assurance matters.

Duties

Implement, train, and maintain a web based audit system that will allow for the department to submit, document, and retrieve relevant inspection data for analysis, reporting, and trend changes.

Introduce and implementation of standards to obtain organizational recognition that is industry recognized or compliant with government trends in environmental/green practices.

Develop life cycle cost analyses of Quality projects and programs.

Implementation and coordination of trainings specific to lines of business within the Contract Operations Department. Training for employees that focus on CO initiatives such as custodial tasks, “green” cleaning, and other identified training needs.

Analyze inspection results for trends, unusual situations, safety considerations, and team/staff adherence to quality standards and objectives.

Perform organizational manpower studies.

Research and investigate new or improved business and management practices for application to agency programs, procedures or operations at different federal agencies contracts.

Perform studies and make recommendations to process and quality improvements to increase service efficiency and effectiveness.

Quality Engineer, Compliance Officer, QA/QC Advisor Dec 2001 – May 2010

Astrazeneca, Inc. (IPR Pharmaceuticals) Canovanas, PR. 00729

Support internal and external audits conducted in the facility (FDA, MCA, etc). Develop audit schedule and plans, including functional responsibilities, specific project assignments, and audit objectives and requirements. Present findings and recommendations on issues or problems impacting major programs in accordance with regulations and standards.

Duties

Ensure quality and regulatory compliance of the site, drive process effectiveness, efficiency and approve documentation such as: Supply Chain, Operational procedures, Technology transfer, Cleaning and Process Validations, Equipment Qualification, Reliability, IS/IT and SAP among others.

Manage the implementation of the project plan, along with operating regular controls to ensure that there is accurate and objective information on performance relative to the plan, and the mechanisms to implement recovery actions where necessary.

Follow up the major phases or stages, including feasibility, definition, project planning, and implementation, evaluation and support/maintenance, measure and report results.

Review reliability plans for critical facility including PM and related activities. Ensure works of real property and facilities maintenance and related engineering services were done correctly in accordance to the established guidelines and regulations.

Lead Root Cause Failure Analysis efforts and train technical staff on failure analyses protocols.

Provides policy recommendations, leadership, and technical support in project lifecycle management.

Communicate and resolve manufacturing site SQA issues for the Department and contractor management and other areas and sites stakeholders.

Review QC programs, documented defects, databases, train employees, and run automated test.

Prepare and recommend for approval QA and SQA programs, implementation plans, and implementing procedures.

Responsible for leading complex projects, across organizational and different manufacturing sites.

Defines factors as customer “critical to quality”, process and continuous improvements on keys initiatives that result in significant improvements in manufacturing products and service delivery, reduced operational unit costs, increased quality, and reduced process cycle time.

Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes.

Establishes statistical confidence by identifying sample size and acceptable error; determining levels of confidence.

Establishes statistical reliability by using mean time before failure, Weibull 3-parameter distribution, reliability modeling, and reliability demonstration tests.

Develops experiments by applying full and fractional factorial techniques.

Develops sampling plans by applying attribute, variable, and sequential sampling methods.

Maintains statistical process controls by applying demerit/unit, zone charting, x2 charts for distributions and individual-medial/range for multi-stream processes.

Analyzes data by completing hypothesis, normal distribution, and process capability analysis tests.

Prepares reports by collecting, analyzing, and summarizing data; making recommendations.

Contributes to team effort by accomplishing related results as needed.

Serves as primary QA representative responsible for the scheduling, conduct and reporting of audits.

Coordinate and support inspection readiness and regulatory inspections.

Validation Specialist Aug 2000 - Dec 2001

Washington Group, Inc Rio Piedras, PR

Duties

Development, execution, revision and approval of documents related to engineering, computer, cleaning and process validation.

Development and execution of experimental programs, equipment qualifications, operational procedures and manufacturing production documents for diverse equipment, processes and technologies.

Development of final validation and qualification reports.

Assist and participate in validation teams.

Perform, analyze and document physical product tests for SPC.

Perform planning, integration and execution of industrial engineering work external to the organization.

Through review and analysis of production reports and inspections, evaluate the effectiveness of internal and external engineering operations.

Determine causes of unfavorable trends and variations.

Buyer Sep1998 - Aug 2000

Stryker Corp Arroyo, PR

Duties

Work with the Area Supervisors alternatives to agree on the best sequence to meet the schedule and prepare production schedule.

Maintain MRP system to monitor the production data for an accurate capacity report.

Verify and follow process order completion to assure supply chain feed.

Maintain adequate inventory levels.

Analyzes BOM’s, item master, routings, specifications and others to ensure that the planning system reflects current capabilities and capacity.

Prepare production capacity reports.

Monitors inventory levels according to stock policies with the weeks of cover report monthly.

EDUCATION:

College: Polytechnic University of PR

Major Field of study: Industrial Engineer

Type and year of degree(s) received: Bachelor of Science, 06/1998

JOB RELATED TRAININGS:

Six Sigma Black Belts (2014)

OSHA 30 hours Course (2013)

Custodial Technician Training Program (2012)

CIMS Expert Certification (2012)

Train the trainer (2011)

Quality by Design (Nov 2009)

Audits (Sept 2009)

AstraZeneca Project Management Framework: Course for Project Leaders. (Jan 2009)

Seven Habits of Highly Effective People (July 2008)

Risk and Reliability Assessment (Oct 2007)

Implementing Key Requirements for Validations (Apr 2007)

Fundamentals of Quality Engineering (Apr 2006)

Facility Qualification (May 2005)

Flow of solids in Bins, Hooper's, Chutes and Feeders Seminar (Feb 2004)

Negotiations (Dec 1999)

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