quality engineering manager resume example with 12+ years of experience

Jessica Claire
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Electrical Engineer with more than 10 years in the Manufacturing / Automation Engineering field, results-oriented and committed to achieve the goals in any engineering and manufacturing company.

Results-oriented and dedicated team player with knowledge of electrical engineering concepts, FDA environment and manufacturing process with a creative aptitude for new challenges. Seasoned success at coordinating diverse projects and staff, improving departmental processes, and increasing revenue.

  • Root cause identification
  • Non-conformance processes
  • Quality assurance experience
  • FDA / CFR 210, 211, 820 and Part 11.
  • Excellent analytical and problem solving skills / Troubleshooting.
  • Root Cause Analysis.
  • Non-conformance reports.
  • Quality improvement strategy.
  • Process optimization.
  • Process control documentation.
  • Clear and effective communication.
  • Employee training and developing.
  • Ability to quickly learn and apply computer applications or new software.
  • Ability to lead and influence to provide positive change within organization.
  • Data collection
  • Mathematical calculations
  • Proficient with Microsoft Office, Google, Infinity IQS and SAP.
  • Work ethic.
  • Computer skills.
  • Teambuilding
  • Project planning
  • Analytical
  • Team management
  • Supervision
  • Ladder Logic, Automation, Digital Electronic,
    Motor Control / Servo - HMI’s,
  • Resource Management.
  • Deliver high-level projects on time and within budget, develop and maintain manufacturing methods and create process routings and manufacturing instructions.
  • Drive process improvement / cycle reduction initiatives via safety and productivity improvements.
  • Manage high impact process and quality improvement projects yielding significant reduction in defects and increased productivity in the work group / department.
  • Utilize lean-manufacturing principles and participate in action workouts to improve process capability.
  • Reduce overall costs and increase capacity.
  • Expertise to solve problems, develop and execute objectives for self and others, and have the ability to achieve short-term and long-term business goals.
  • Reliable and trustworthy
Quality Engineering Manager, 07/2018 to Current
PwcSan Antonio, TX,

Quality Engineer Manager.

Lead a team of 04 Quality Engineer responsible of planing, organizing and executing qualifications in a FDA regulated facility.

  • Ensure that the Master Validation Plan is Updated for Regulatory documentation to support compliance for the facility.
  • Ensure that the proper Qualification / Validation process was developed and executed to meet expectations with regards testing, acceptance criteria and documentation.
  • Developed and executed Qualifications Protocols for different systems such as USP Purified Water Systems, Controlled Environment rooms (CERs) ISO 14644-1:2015, Compressed Air ISO 8573, Converting lines and Blending Systems. These Qualifications included: Installation Qualification, Operational Qualification, Performance Qualifications, Cleaning and Sanitization Qualifications, Dirty Idle Hold Time and Infinity QS qualification (Statistical Process Control Software), Blending Qualifications for multiple costumer's formulations, Product Push and Co-Mingling Studies.
  • Use statistical tools such as InfinityQS or MiniTab for Cpk analysis during and after qualifications in order to establish if the process is in state of control and compliant with the Manufacturing Specifications or System's requirements.
  • Research, assess and purchase the necessary equipment and instruments needed to perform the Operational/Performances Qualifications with regards the Facility Systems and Converting Lines. This also included to manage and maintain the proper documentation for the calibration certificates within the facility prior and after a qualification event.
  • Provide guidance to the leadership team with regards any Quality Issues / Non-Conformances due system failure or design flaw, by using statistical data, trends, field observations and performances reports.
  • Responsible in developing and managing the Management of Changes related to any new asset, system, equipment or technical change within the facility.
  • Ensure that all the lines and equipments from Blending to Converting OTC products and Medical Devises sold within US and Canada made in the Contract manufacturing facility meet registration as part of FDA requirement and any regulatory requirements.
  • Provide Monthly and Annual Quality training that includes Process Qualifications and Quality Systems.
  • Review and ensure that the records of quality reports and statistical reviews are kept.
  • Analyzed quality control test results and provided feedback and interpretation to production management or staff.
  • Troubleshot product issues, design gaps, quality issues and fixed problems.
  • Established and ensure that the product specifications and quality assurance practices are validated and implemented in daily operations.
  • Collected and analyzed production samples to evaluate quality.
  • Monitored product trends and suggested changes.
  • Appraised customers' requirements and worked to maintain high satisfaction.
  • Responsible in developing with the Quality Systems, the site quality Internal Audit programs / plan.
  • Responsible for managing the execution of the CAPA / Non-conformances programs related to validated systems or converting lines in order to meet the expectations of the Quality Policies, Standards and Costumer's requirements.
  • Contributed to root cause evaluation to mitigate risk and foster continuous improvement.
  • Collaborated with quality team members and leaders to monitor conformance to quality standards.
  • Provided spot troubleshooting of unexpected issues with products, manufacturing and design phases.
  • Performed root cause analysis for detected faults and developed corrective actions.
  • Reviewed purchase orders to properly scale asset flow requirements, reducing waste and supporting availability.
  • Drafted process documentation to standardize operating procedures and techniques.
  • Established product specifications and quality assurance practices.
  • Troubleshot product issues and fixed problems.
  • Developed inter-disciplinary cross-training programs to expand competencies among employees and reduce knowledge gaps.
  • Demonstrated strong knowledge of company standards and protocols during qualifications.
  • Facilitated improvement protocols to decrease error rate and mitigate non-conformance.
  • Supported the Operations team in implementing corrective actions to increase quality.
  • Created professional, to-scale sketches to communicate and clarify special requirements.
  • Planned, scheduled and coordinated detailed design phases of large-scale multiple projects during the start-up phase.
  • Utilized mathematical skills and understanding of engineering principles to improve equipment design.
Planner, 08/2017 to 07/2018
DanaherRomulus, MI,

Plant Planner of Toothpaste Plant (STA).

  • Responsible for managing the replenishment of materials.
  • Ensure adequate inventory levels are maintained in order to meet production plan goals.
  • Optimize production scheduling and delivery times in SAP, reducing downtime in production lines due to lack of materials by 25%. Improve consumption forecast accuracy and safety stock levels, reducing costs of freight shipping by over $100,000 in Q1 2018.Assessed current inventories and brought in supplies to keep stock within optimal levels for expected demands.
  • Purchased rolls of laminate to maintain stock in the Mission Hills Plant (Mexico) needed for manufacturing of laminated tubes in the toothpaste plant in Morristown, TN.
  • Documented production information showing volume produced, safety stocks and case fill data.
  • Developed an improvement project plan that allowed the facility to prepare and respond better in the in planing type of SKUs based on their complexity
  • Exceeded Planing expectation by finding creative solutions to problems in the shipping process that resulted in cost savings and improved delivery times.
  • Identified potential issues and resolutions with inventory and quality while introducing new products, engineering changes and customer conversions.
  • Maintained steady flow of material without exceeding resources and kept manufacturing lines operational.
  • Leveraged real-time and historical data and SAP tools to improve development of planing projects.
  • Improved results continuously by conducting thorough reviews of events' successes and failures.
Operations Team Leader, 11/2015 to 07/2018
E. & J. Gallo WinerySacramento, CA,

Operations Team Leader of Toothpaste Plant.

  • Leading the operations of Making, Tubes, Finishing and Warehouse.
  • Developed the team by the use of technical training and people skills to enhance output results and team work environment across shifts.
  • Collaborate with quality, safety, and planning departments to ensure all plant goals are achieved in the most efficient method.
  • Provide strong and efficient leadership for first, second, and third shift team members, which has allowed the teams to consistently increase the performance and productivity.
  • Determined effective schedules and managed daily workflow.
  • Assisted with development and implementation of quality controls, productivity standards and compliance guidelines.
  • Supervised 25+ team members, offering constructive feedback on work performance.
  • Kept team in compliance with all applicable company and legal standards.
  • Supported team objectives by coordinating Operations, Quality, EOSH and Factory Performance and Reliability Program resources.
  • Generated daily reports detailing operational performance as compared to targets.
  • Trained, mentored and motivated employees to maximize team productivity.
  • Maintained safety and emergency readiness among personnel by disseminating information on and monitoring compliance with regulatory and organizational policies.
  • Developed initiatives for process improvement and reviewed and assessed ongoing operations.
  • Built upon established practice standards to improve operational performance and reduce labor costs.
  • Evaluated invoices and shipping paperwork for accuracy and compliance.
  • Reduced process lags and trained team members on best practices and protocols.
  • Drove solutions to predominant operations issues by identifying areas of deficiency and performing root-cause analysis.
  • Defined appropriate metrics and measurements to drive results.
  • Identified operational and performance issues and worked with managers to resolve concerns.
  • Coached team on company policies, procedures, and best practices to enhance operational efficiency, employee productivity and subsequently decrease labor costs.
  • Served as liaison between certain departments to implement new improvement plans and changes.
  • Wrote reports outlining results to facilitate management decision making.
  • Improved the coordination between Making Area, Aisa area (Laminated Tubes) and Finishing through multiple EMOs, that allowed the company to transition between formulations without major downtime and impacting bussines performance.
  • Compiled and verified data to resolve issues and streamline efficiency.
Instrumentation Spec/Engineer, 05/2015 to 11/2015
Discover Financial ServicesRiverwoods, IL,

Instrumentation Specialist / Controls Engineer (Maintenance / Engineering)

  • Responsible of Continuous improvement projects, applying automation and electrical engineering skills for the optimization of manufacturing processes.
  • Installed Krones Blow mold for Bottle line, increasing performance of the line by 29% for Q3.
  • Performed troubleshooting using P&ID system diagrams and electrical schematics.
  • Collaborated with multiple engineering disciplines to support research activities.
  • Maintained and repaired peripheral equipment by troubleshooting and completing hands-on adjustments.
  • Developed standard operating procedures for instrumentation use, accounting for worker safety and related protocols.
  • Scheduled and oversaw preventive maintenance plans, verifying proper operational parameters.
  • Integrated accelerated testing techniques into diagnostic procedures to shorten work completion time.
  • Aided in developing safety training programs, incorporating guidelines such as Process Safety Management, OSHA requirements and other related standards.
  • Prepared, reviewed and updated drawings, diagrams and wire connections.
  • Installed, repaired and programmed programmable logic controllers and variable speed drives.
  • Used CAD software to create models and simulations for use by manufacturing team.
  • Aligned, fit and troubleshot problems with electro-mechanical components.
  • Identified surface defects through visual inspections and corrected problems to optimize quality.
  • Identified and implemented opportunities for conserving energy and resources.
  • Used precision instruments to test performance and verify dimensions.
  • Outlined electromechanical test results in written documentation for management or other personnel.
  • Used multimeters, oscilloscopes and other hand tools to test and evaluate components.
  • Soldered components onto boards, reworked arrangements and installed wiring.
  • Applied troubleshooting techniques to determine cause of malfunctioning systems.
  • Inspected and tested completed systems for performance and conformance with specifications.
  • Utilized diagnostic techniques and test equipment to assess electromechanical circuits, equipment, processes and systems.
  • Collected dimensions and power requirements to complete accurate designs.
  • Helped to calculate loads and select equipment and wiring adequate for project requirements.
  • Determined root cause analysis and testing activities.
  • Led cross-functional project teams of 5 staff members to achieve on-time release of products.
Team Leader, Team Leader, 06/2011 to 10/2014
EvonikBirmingham, AL,

Team Leader of the Oral Care Plant. (Valencia - Venezuela)

  • Performed management tasks in the plants responsible for providing the laminated tubes for toothpastes and toothbrushes that supply the national demand.
  • My main responsibilities were: autonomous maintenance, quality, standards of continuous improvement in plant performance, training and personnel management, project innovation and system design automation.
  • The efficiency of the Toothbrush plant under my supervision had a sustained increment of production by 11%., Palmolive) Automated Registration of Production (Laminated Tubes Plant @ Colgate Palmolive) Delivered Founding in the Growth & Financial Goals project reducing in 4% Material Losses in 1 Year (Toothbrush Plant @ Colgate Palmolive) Automated Winder PVC film for the Refill Station (Hoonga Blister Machine) - (Toothbrush Plant @ Colgate Palmolive).
  • Kept work areas clean, neat and free of safety hazards to maximize efficiency.
  • Delegated daily tasks to team members to optimize group productivity.
  • Promoted to leadership position in recognition of strong work ethic and provided exceptional customer service.
  • Fostered positive employee relationships through communication, training and development coaching.
  • Mentored newly hired employees on machine operations and implemented training on safety procedures to prevent injuries.
  • Conducted inspections of equipment before, during and after shifts to immediately resolve issues that could cause project delays.
  • Developed and implemented policies, procedures and process improvement initiatives to improve retention rates and increase customer satisfaction.
  • Interviewed, hired and trained new quality customer service representatives.
  • Identified equipment issues using troubleshooting techniques to keep machinery fully operational during shifts.
  • Reviewed specifications and directions carefully to determine precise set up for production equipment according to specifications.
  • Monitored team progress and enforced deadlines.
  • Counted inventory, resolved discrepancies and completed paperwork to keep system accurate and current.
  • Integrated process improvements to increase overall workflow.
  • Developed and monitored weekly staff schedules.
  • Documented production levels, materials used and special incidents to keep management informed of daily activities.
  • Kept work flowing smoothly in and out of department by working closely with shipping, warehouse and other personnel to coordinate movements.
  • Rotated through series of different stations based on team needs.
  • Followed staffing strategies to achieve production goals.
  • Assessed, motivated and empowered team members to work to build better work relationship between multiple departments which resulted in better working environment, employee satisfaction, production performance / growth and AU improvement.
Automation Specialist Engineer, 01/2011 to 06/2011
Education Realty Trust Inc.Fremont, CA,

Automation Specialist Engineer. (Valencia - Venezuela)

  • Worked on the design and development of industrial automation applications, which are based on the use of servo technology and linear motors, drives, programmable controllers and mechatronics equipment.
  • Led the Electrical Engineering Dept. and Design team in the launch of the third production line of 3M sandpaper throughout Latin America, improving the efficiency and production capacity of the line by 15%.
  • Developed modifications for ongoing and completed projects to ameliorate performance weaknesses and discovered faults.
  • Performed critical design reviews of proposed final products, applying necessary business goals and regulatory requirements to prototypes.
  • Maintained deep knowledge of business process activities and development strategies.
  • Participated in project requirement reviews, contributing to logistical planning tasks and other technical forecasts.
  • Served as technical resource for operations personnel, answering queries and advising production staff.
  • Maintained timely and accurate oral and written technical reports of engineering activities.
  • Monitored design processes from conceptual phase through construction.
  • Produced 2D and 3D design drafts using hand drawings and AutoCAD software.
  • Researched and analyzed customer design proposals, specifications, manuals and other data.
  • Partnered with other engineering staff members on projects to offer continual engineering expertise for safe and accurate project results.
  • Spearheaded engineering technical support for designers of prototypes.
Plant Engineer, 01/2010 to 12/2010
Empresas Polar C.ACity, STATE,

Plant Engineer (Maintenance / Engineer) (Valencia - Venezuela)

  • Worked at POLAR Top Brewing Company in Venezuela) in the implementation of new Programmable Logic Controllers and engines for the plant.
  • Developed new catalogs in SAP R3 system, new system for checking failures and supervision of maintenance plans within the company.Thanks to this, unplanned downtime decreased by 8% in the manufacture of crown cover.
  • Evaluated plant operational processes and documented possible improvements and implementation plans.
  • Designed standard operating procedures for tasks such as material handling, conveying, can line processing and filing.
  • Served as subject matter expert on automation, educating visiting personnel and customers on technical facts and operational realities.
  • Served as technical resource to initiate and improve processes related to machines PLC.
Physics and Math Instructor, 10/2009 to 11/2012
Advanced Formation Center Proncimed C.ACity, STATE,
  • Taught college level Engineering (Physics and Math) and Abstract Reasoning to medical students.
  • Coordinated activities within the training center such as financial management and community representation of the school.
  • During my management 65% of the students utilizing the training center maintained the highest grade point averages in the physics and mathematics courses of the University of Carabobo.
  • Employed teaching and learning strategies that challenged abilities, interests and intellectual curiosity of students.
  • Planned and organized instruction and instructional delivery in innovative ways, maximizing student learning and academic excellence.
  • Evaluated and expeditiously returned student work to promote maximum student learning and engagement.
  • Encouraged development of communication skills and higher critical thinking skills through appropriate writing assignments, classroom presentations and experiential learning.
Marketing Associate, 04/2009 to 07/2010
Hardware EPA CCity, STATE,
  • Worked as inside sales and logistics representative.
  • Interacted with customers and vendors.
  • Created and led a project to increase sales of the company and taught vendors better strategies to achieve the goals proposed.\
  • Supported marketing team in developing promotional strategies and targeted campaigns.
  • Managed client marketing strategies and product promotion campaigns.
Education and Training
MBA: Quality, Expected in 09/2014
Universidad Technological Del Centro - Valencia,
Electrical Engineer: Systems And Automation, Expected in 07/2011
Universidad De Carabobo - Venezuela,
Native/ Bilingual
Full Professional
  • Exchange PLC and modernization of electrical panel in the Tufter Zahoransky (Toothbrush Plant @ Colgate Palmolive)
  • Automatic Feeding System for the Blister Machine (Toothbrush Plant @ Colgate Palmolive)
    Cermex-Fanuc Robotics palletizer installation (Filling Plant @ Colgate Palmolive)
  • Automated Registration of Production (Laminated Tubes Plant @ Colgate Palmolive)
  • Delivered Founding in the Growth & Financial Goals project reducing in 4% Material Losses in 1 Year (Toothbrush Plant @ Colgate Palmolive)
  • Automated Winder PVC film for the Refill Station (Hoonga Blister Machine) - (Toothbrush Plant @ Colgate Palmolive)

1.- Quality Management / Compliance in Pharmaceutical Industries Training - The Center of Professional Advancement - In Progress.

2.- ProFicient Fundamentals Course (Infinity IQS) - 2020.

2.- FDA Process Qualification (IQ/OQ/PQ) in Pharmaceutical Industries Training - The Center of Professional Advancement - 2018.

3.- Process Control and Automation - Polk State College - 2015.

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Resume Overview

School Attended

  • Universidad Technological Del Centro
  • Universidad De Carabobo

Job Titles Held:

  • Quality Engineering Manager
  • Planner
  • Operations Team Leader
  • Instrumentation Spec/Engineer
  • Team Leader, Team Leader
  • Automation Specialist Engineer
  • Plant Engineer
  • Physics and Math Instructor
  • Marketing Associate


  • MBA
  • Electrical Engineer

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