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6-10 years of experience
Scope of responsibilities includes Enterprise Lead Auditor for Caterpillar Quality Management System (QMS), QMS facility coordinator for Advanced Components and Systems Division (ACSD), Diversified Products Division (DPD), and Large Power Systems & Growth Markets (LPSGM).
- Collaborate with enterprise product and manufacturing organizations to drive continuous improvement to processes, systems, and training materials for 41 facilities.
- Successfully led the adoption of a standardized quality system used in 85 facilities worldwide with more than 100,000 employees.
- Recognized as Lead Auditor on certification process of 46 facilities.
- Integral leader developing and deploying of ISO9001 compliant QMS for Caterpillar that leveraged existing best practices.
- Authored and developed tracking model which monitors 185 Caterpillar facilities and quality certifications.
- Developed training program for internal quality personnel and successfully trained more than 500 employees on Caterpillar Quality Management System and ISO 9001 with an ongoing organizational cost savings of $1M to date.
- Consistency in training program delivered exceptional key quality goals achievements in: Customer Satisfaction, Continuous Improvement, Timeliness, Accuracy, Efficiency, Cost Savings, Vendor Certification, Internal Quality Certification, ISO 9000 Certification.
0-5 years of experience
Reviewed and validated GD&T Drawing prints, Process Control Plans, Material certifications (ASTM standards), Gage R&R
study, PFMEA and process capability study (Cp/Cpk) for 100+ suppliers worldwide
- Educated suppliers about the company quality standards and timely communication with them for closing the quality
- Executed Control plans, PFMEA, Six Sigma & Lean production and acted on process related issues using 8D to close NCCR
- Executed warranty improvement project at supplier end to reduce warranty claim cost which resulted in $61,000 savings
- Awarded ‘Star Team of the Month’ for TurfCare platform’s excellent delivery of project
0-5 years of experience
Developed and implemented Quality Procedures and Systems following the QS-9000 standard and train Associates for a successful QS-9000 certification.
- Lead APQP team during new product launches and responsible for PPAP submissions.
- Developed and negotiated with Customers boundary samples to standardize acceptance criteria between both companies reducing the PPM’s.
- Improved Quality Checklists identifying the key characteristics to be monitored in order to prevent a fit / function issue reducing the customer complaints.
- Customer Liaison keeping a good communication and positive business relationship with Customers.
- Developed, implemented and managed visualized statistical controls of key quality characteristics for critical components, which enabled faster response time and resulted in scrap reduction.
0-5 years of experience
Drive continuous improvement and ISO compliance by leading factory floor audits in targeted areas. Provide oversight and prioritization of metrology resources. Partner with design and manufacturing stakeholders to develop and implement design changes, process improvements, and rework methods for high-value parts. Serve as point of contact for international, domestic, and on-site customers to ensure quality assurance questions and concerns are addressed.
- Led cost-benefit analysis and project execution to upgrade CMM capabilities for the facility, resulting in $400K in savings.
- Headed project involved in relocating metrology equipment (PMM machine and gage lab) to a new building location that enabled a 33% reduction in floor space.
- Instrumental in saving $30K by use of creative packaging and transportation of PMM machine during move.
- Successfully reduced gage inventory by 23%, resulting in significant recertification and storage cost reduction.
0-5 years of experience
Orthopedic components and implants manufacturer using CNC mills, CNC lathes, and diverse metals for medical devices. Accepted contract offer from bioMereiux.
- Class III Product and Process Validation leader, implemented and completed test method validations (TMV) at all stages of manufacturing: linear measurements, weld verifications, material properties.
- Validations included Installation, Operational, and Performance qualification activities for FDA and customer compliance, including first article documentation.
- QMS standardization; participated in ISO 13485 and 21 CFR Part 820 systems improvments and successful ISO surveillance and registration audits.
- Implemented real-time SPC and managed gage calibration, coordinated all quality planning.
0-5 years of experience
Developed and maintained quality engineering methodologies, systems, and practices to fit company, customer, and regulatory standards
- Supported Quality System, including Complaint, CAPA, Design, Supplier Quality, Document Control and Product Release processes
- Presented Quality System metrics to senior management and conducted weekly field installation quality reviews with customers
- Trained engineers and associates in Six Sigma/Lean practices and lead multiple kaizens. Earned Lean Greenbelt certification
- Designed and implemented test fixtures and software automation processes for new products, from prototype to production. Developed test plans, including scheduling and cost assessments
- Proposed new factory-wide test automation system to integrate customer test tools, proprietary test tools, and online applications. System was approved and successfully deployed. Assigned as lead engineer to expand the system to other product lines throughout the factory
0-5 years of experience
- Inspected all categories of heavy equipment involved in the construction industry following all safety procedures and maintaining an accident free workplace.
- Prepared inspection report and photos to be uploaded to company website within 72 Hrs. from delivery which help customers to identify equipment specification, condition and satisfied consigner about his machine marketing.
- Tasted machines and reported any default to yard Management for repairing through workshop mechanic which present machine in best condition to get higher value.
- Read equipment catalogue for each auction and corrected all items specifications, information and description which reduce customer complains.
6-10 years of experience
Statistical Analysis (Q-Stat), tracking & reporting of internal and external quality data. Prepared and distributed information packages including data sets, summaries and charts for quality metrics.
- Managed and maintained databases for quality metrics and tracking.
- Supervised 6 hourly quality team members.
- Managed the CMM Reporting System.
- Experienced in APQP, PPAP, FMEA, SPC, MSA, control plans and ISO & TS 16949.
0-5 years of experience
Establish control plans for new and existing processes based on capability and historical run data.
- Facilitate root cause analysis and work with production and engineering groups to develop corrective actions.
- Coordinate company service logistics with internal personnel and contractors to ensure precise and timely preventative and corrective maintenance as well as new system installs.
- Developed and implemented processes to ensure the highest level of quality compliance.
0-5 years of experience
- Built an ISO9001 ready quality management system from the ground up.
- Established the product reliability test standards and specifications.
- Managed three labs of more than 20 various advanced testing equipment.
- Assisted the R & D group to characterize new formulations.
0-5 years of experience
Aluminum diecast, machining & assembly for automotive and furniture
- Updated & maintained quality systems, ISO 9001
- Trained Quality Engineers and auditors
- APQP, PPAP, corrective actions, customer contact
0-5 years of experience
- Supported quality initiatives associated with injection molding of automotive seals
- Managed PPAP requirements for cognizant parts
- Performed Failure Mode Affect Analysis (FMEA) on processes and products
- Employed statistical techniques to monitor and control processes
- Developed and conducted system, product and process audits
- Determined root-cause analysis; implemented corrective and preventive action
- Participated on Kaizen Events
- Developed Suppliers
0-5 years of experience
Responsible for maintaining the quality and integrity in order to meet customer needs
- Reviews and diagnosis defective material rejected during manufacturing process. Identify the need for corrective action.
- Provide customer support on existing programs.
- Responsible for all aspects of quality performance to final customer including new production introduction and PPAP approvals.
- Develop and maintain quality all quality documents such as control plan, PFMEA, and work instructions.
- Assist in maintaining TS16949 status.
- Voice of the customer. Main point of contact for all customer concerns.
- Utilize advanced problem solving tools to develop solutions to internal quality problems.
0-5 years of experience
Plant level leader for Quality department, including supervision of four Quality Techs. Also performing Quality Engineering duties as needed to support the facility.
- Day to day operations support for corrective actions, supplier non-conformances, auditing, and QMS/ISO activities.
- New Product Development support including PPAP plan creation and review, project review, and pre-launch activities necessary for successful product introduction.
- Support weekly and monthly Quality metrics reporting to plant and corporate levels.
- Sustaining activities include approval of Engineering change orders, control plans, process changes, and troubleshooting.
- Responsible for training Quality Techs and Line Leads in basic problem solving.
0-5 years of experience
- Ensured and improved quality of cast, forged, and fabricated products for Minerals Processing (Comminution) and Cement Technology for achieving Customer Satisfaction.
- Provided close technical support to engineering and quality, refinement of vendors’ existing processes, qualification and development of new sources, and troubleshooting of manufacturing problems as they occurred.
- Reviewed, refined, and implemented more than 50 different testing, inspection, and manufacturing standards for fabricated, cast, and forge components pertaining to minerals and cement processing products.
- Studied suppliers’ quality plans (ITP) and manufacturing procedures to ensure resulting products complied with applicable codes for internal and customer specifications.
- Performed and followed existing and new Vendor assessments to ensure that new suppliers possessed resources to meet expectations, and that existing suppliers’ commitment of capabilities and resources remained focused on objectives.
- Developed technical dispositions for non-conforming product that included fitness for purpose evaluations as well as formulation of appropriate corrective and preventive actions plans.
- Performed surveillance activities for new and critical project suppliers. Advised vendors, when necessary, on how to fulfill quality requirements for cast, forge, and fabricated components.
- Conducted manufacturability studies on new and existing product designs for optimizing quality, cost, and delivery of finished product resulting in 20+ cast components reviewed for enhancing castability.
0-5 years of experience
- Led a team of 15 people for the Verification of PET/CT subsystem and conduct daily stand up meeting to assign tasks.
- Review of test cases, execution of tests, reporting on test results and gathering objective test evidence through product lifecycle management software. (HP ALM)
- Submitting/resolving detailed defects/issues for PET/CT system in compliance with the Quality Management System through defect tracking software. (Clearquest)
- Attending and leading technical reviews, tracking action items, driving closure weekly status reporting to the management, system usage schedule planning and creation of verification documents such as plan, trace and report.
6-10 years of experience
Prepared QS – 9000 Quality System & Manual to obtain registration
- Conducted Internal Audits to the QS – 9000 Standard
- Prepared Failure Mode & Effects Analysis for new products
- Facilitated Heat Treat Furnaces (VZKQ) to heat treat client components
- Responsible for Machine Operator Procedures and Route Cards
- Prepared Statistical Process Control Charts (SPC) for production components
- Performed daily technical support and trouble shooting
- Prepared all training documentation as well as instructed training classes
- Led team to transition from QS-9000 to TS-16949
- Metallurgical Laboratory Supervisor
0-5 years of experience
- Manage site AS9100 QMS program and United Technologies ASQR-01 compliant quality system. Perform Audits, perform root cause analysis, developed corrective actions (CAPA) and maintaining the UTC Zero Defect Plan.
- Facilitate process improvement teams providing Lean tools and Six Sigma methodology to ship a defect free product while increasing production capacity and reducing costs.
- Prepare PPAP documents including Control Plans, Process Drawings, PSW’s and PFMEA’s.
0-5 years of experience
Provided support to the development and production of class I and class II medical devices. Represented quality in production process efforts, quality planning, PFMEA, risk analysis and supported new product and introduction development activities. Supported finished goods variance investigation and resolution, complaint investigation, process improvement and quality assurance testing methodology.
- Incoming Quality Control Supervisor
- Assured that the personnel complied with the FDA Quality System Regulation and ISO Standards
- Participated and performed IQ/OQ/PQ activities
- Independently led problem solving efforts to identify and resolve quality issues
- Independently performed machine and process capability and performances studies
- Solved customers’ complaints and related management of supplier corrective actions
- Quality Engineering Supervisor, Supplier Engineering Supervisor
0-5 years of experience
Supporting operations goals for quality and reliability, continuous improvement, and problem solving. Develop, establish, and maintain quality engineering methodologies and practices, which meet BSC, customer, and regulatory requirements.
- Control manufacturing process defects by leading efforts focused on identifying primary root causes and implementing corrective and preventative actions.
- Develop and coordinate the execution and documentation of Design Validation and Verification activities to confirm design and to support regulatory submissions to Notified Bodies and FDA.
- Participate in development of product risk management tools.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Support the determination and implementation of Design controls based on Risk Management, Customer Needs and Manufacturing Input.
- Application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards.
- Support the Design Control System during audit activities (DEKRA audit, Internal mock audit).
- Establish and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints) for In-House Tissue fixation.
- Supervise Quality Inspectors for manufacturing production group. Ensure inspectors are cross trained and allocate resources for inspection processes.
- Supervise Operations Quality Engineer I. Mentor and provide guidance regarding Nonconforming Reports, Material Review Board, engineering protocols/reports and trending production quality metrics.
10+ years of experience
Support manufacturing facilities with Quality Engineering issues gage design, validations, and all applicable documentation as required.
- Answer complaints.
- Work on new product implementation.
- Programming Zeiss CMM and OGP automated inspection equipment.
- Quality training as required.
- Assist Engineering, inspection, and calibration staff with gauging or quality related issues.
- Design of gages, and perform product analysis using PRO Engineer CAD system.
- Projects as required to support Synthes marketing strategies world wide, interfacing with compliance, product development.
0-5 years of experience
- Full responsibility for Mercedes Benz M Class Center Console production launch in Sept 2018.
- Quality engineering support for all BR167 Phase reviews and approvals, introduce 12 new molds to injection department, technical component specifications of M Class Center Consoles, Supplier Quality Management System (SQMS) to Daimler Benz in Tuscaloosa, Alabama.
- Manage the Grammer Production Systems to track line failures to drive corrective action for control internal and external PPM’s.
- Left company after policy using their internet to check on a sick family member.
6-10 years of experience
- Serve as customer contact for Quality System qualification (for the customer’s Supplier Quality processes)
- Serve as Scribe during FDA inspections
- Field action implementation to notify customers of product corrections, monitored progress of implementation, notification to regulatory bodies
- Review and revise customer notification agreements to align with the organization’s processes
- Primary contact for customer audits and serve as company representative during audits.
- Developed design change control processes for laboratory automation group
- Coordinated and implemented the internal audit process for the Indianapolis facility
- Coordinated resolution of customer complaints and technical support issues for the lab automation group
0-5 years of experience
- Coordination of QA auditors and QA Engineers
- Responsible for 8D reports follow-up and closure with DIRECTV customer
- Implementation and follow-up of Corrective & Preventive actions to avoid fails/ defects with customers
- Corrective and preventive actions follow-up
- Improves to KPI: IPQC In-Process Quality Control, ETT: Extended Temperature Test, IQC fails in customer’s audits.
- Preparation of Documentation: PFMEA, Visual aids, work instructions, Quality alerts
- Contact with DIRECTV customer via: Conference calls & e-mail
- Coordinate Quality stations on PD line
0-5 years of experience
Implement Scrap / RPV (Return Product to Vendor) Process
- Maintain TS 16949 Quality Management System / BIQS
- Implemented LPA (Layer Process Audit)
- Establish Training Program for Salary Quality Engineers & Supervisors
- K2XX Platinum Escalade Launch
- Tier 1 Customer for GM ( All Seating Assembly)
- Implementing Calibration Program
- Implementing Quality Laboratory to complete GM “H” point data
- Implementing LAT on our final seats for Appearance Approval
- Zero PPM with GM for 2015
- Supplier Development with our top 6 suppliers (Stamping & Welding)
0-5 years of experience
Corrective actions of every customer complain.
- Control of Visual aids, CP, PFMEA and quality alerts.
- Implement action plan for every customer to follow all the issues and take a conference meeting every week.
- Customer service.
- PPAP for engineering changes and launch projects.
- Lead the quality meetings with the customers and internal issues.
- Improvement and Development Quality Formats.
- Creating Reports for Personnel Administration, and quality department.
- Reduce the PPM’S with the customer improving some operations on the line and improve the escape method as well.
- Remove the containment with the customer (NISSAN) with the implement actions.
- Negotiation skills with customers.
0-5 years of experience
- As the Senior Quality Engineer, exemplifies integrity and influences others with respect to company culture, ethics and procedures.
- Exhibits self-reliance in ability to manage his/her workload and deliver on schedule with decreasing dependence upon management to guide/oversee.
- Consistently produces results that exceed expectations in time frames that benefit the project/team.
- Relates well to all team members and is able to mentor and/or receive instruction as it relates too technical or team related matters.
- Shows ability to fill-in for Leads or Management and moves the project/team forward when either party is not present.
- Initiates action as it is required to ensure project/team success (e.g. mitigate risks, problem solve, provide technical guidance, etc.).
- Communicates clearly and confidently with respect to technical matters both internally and with clients
- Manages Supplier Quality Program
- Supervise Receiving Inspection
- Displays strong English proficiency marked by ability to comprehend/converse in real time, and by effectively presenting material or defending/articulating their position.
6-10 years of experience
- Principle Quality Assurance representative for new product development projects including development of manufacturing processes and review/approval of design and process verification/validation documents.
- Primary Quality Engineer for a recently acquired product line including investigation/disposition of non-conformances and implementation of corrective actions from receiving through release
- Participate in quality system audits by FDA and other regulatory agencies including preparation, direct interaction with auditors and identifying/obtaining records to demonstrate compliance
- Perform on-site quality system audits of component and raw material suppliers and track to closure
- Gather, analyze and present data to global upper management demonstrating compliance with the quality management system, applicable regulations and business objectives
- Led a team of Quality Engineers and technicians in completing root cause investigations as well as adverse event reporting for a wide variety of medical devices used in cardiac surgery
- Led the implementation of custom complaint handling software for 5 facilities in 4 countries including system development, validation, implementation and training
- Track/trend product failures to identify quality issues and act as the QA representative in the implementation of product/process improvements identified through post-market feedback
- Generate, Review and approve Complaint Files, Supplier Quality Notifications, Non-Conforming Product Reports, Risk Assessments/Analysis, Change Orders, Procedures and Test Protocols
0-5 years of experience
- Plan and perform internal audits at various facilities for the Space Communication Network System.
- Organize and facilitate Root Cause Corrective Action meetings.
- Represent Quality Assurance at Software, Hardware and Systems Engineering Change Boards.
10+ years of experience
- Create, manage, and execute test plans for quality verification and validation
- Support product development process through developing test plans, methods, protocols, and reports
- Conduct and participate in design reviews and review of verification/validation testing
- Evaluate test data to provide corrective action with regard to non-conformance and quality product
- Interpret test data, analyze product performance and troubleshoot failed product items
- Recommend changes to simplify and/or improve production
- Prepare and maintain various reports and documents per regulatory and company requirements
- Provide technical support, and operator and maintenance training of product devices
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Senior Quality Engineer
Last edited by: Gabriela Barcenas, CONTENT STRATEGIST -
Gabriela Barcenas
CONTENT STRATEGISTGabriela is a Certified Professional Resume Writer (CPRW) and career adviser. With 10 years of digital media experience and five years of resume writing expertise, her publication history includes fashion, education, travel, social justice, equitable design and career advice.
