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Quality Engineer Resume Samples
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0-5 years of experience
Provided expert leadership in the design of processes to collect and analyze data, establish actionable interventions and measure the effectiveness of clinical and administrative services and compliance with regulatory requirements.
- Led and facilitate process improvement teams providing Lean tools such as Pareto charts, process flow charts, Value Stream Mapping, A3 Reports, basic statistics, control charts, and Lean Daily Management (LDM).
- Prepared training material, One Point Lessons (OPL), Standard Work, and facilitated training and Lunched and Learns on Lean tools: A3 Report, 5S, Huddler Boards, capturing financial benefits (hard and soft savings), Gemba Walks, Identify Waste, process flow charts and value stream mapping.
- Coached VPs’ to enable growth, and innovations.
- Worked with VPs’ and Leadership to aligned strategic plan with projects and business initiatives.
- Worked with stakeholders to develop and implement project strategies and goals focusing on results in areas of improving clinical quality and cost containment and revenue enhancement.
- Developed and trained my team members on Lean tools: Process Mapping, VSM, and A3 Report.
6-10 years of experience
Responsible for the system level qualification testing of medical anesthetic workstations, monitoring equipment, and automated medical information systems and software, to include all relevant documentation and adherence to applicable Quality System Regulations (QSR).
- Developed and maintained product verification and testing documentation that was consistent with Draeger Quality System Regulations and compliant with both ISO 9000 and ISO 13485 standards.
- Performed detailed analysis of returned customer parts and used findings to drive Corrective and Preventative Action (CAPA) improvements.
- Contributed to successful FDA (510(k)) approval of several anesthesia workstation systems and functional enhancements to existing equipment.
- Supported numerous product launches in a clinical environment, to include direct interface with resident anesthesiologists.
0-5 years of experience
Analyzed non-conforming materials and managed supplier corrective action requests.
- Utilized SPC data to identify out of control conditions and calculate supplier capability.
- Lead cross functional teams through the 8D process to identify the root cause of failures.
- Provided over 125 8D reports to multiple customers and initiated 11 corrective actions.
- Experienced with interpreting engineering drawings and creating inspection methods and aesthetic specifications.
- Increased a key customer’s supplier scorecard approval rating from 48% to 80%.
- Experienced with SAP quality notifications, managed process deviations, participated in the daily material review board and was responsible for communicating product and process changes to the change control board.
0-5 years of experience
Validate new product (Safety device for syringes) to comply with US and European regulations. Prepared, executed qualification protocols: FAT, SAT, IQ, OQ, PQ and PFMEA studies.
- Investigated customer complaints, conducted root cause analysis and developed corrective actions (CAPA).
- Ensured compliance to 21 CFR Part 820 and ISO 13485 and customer specifications.
- Reviewed and approved molding validations, including engineering change control to comply with procedures and project objectives.
- Performed Clean Room validations per ISO 14644-1.
- Participated in customer quality audits and responded to findings.
- Involved in six-sigma (cost reduction), statistical capability studies, continuous improvement and safety.
0-5 years of experience
Manage 62 suppliers for quality, improvement, PPAP submission, and issue resolution.
- Lead Auditor for ISO 9001, ISO 14001, and OHSAS 18001 standards.
- Coached and developed internal audit teams.
- Built working partnerships with suppliers to ensure product quality and improved score card performance.
- Eliminated excess inventory by engaging the core team and creating a sustainable culture to continue being effective.
- Developed and implemented new processes relating to corrective actions.
- Lead CAR review and reduced past due CAR’s from 15 to 0 past due.
- Acted as the liaison for the Supplier Quality Department in the absence of a quality manager.
0-5 years of experience
Designed and developed Test Automation Framework using Selenium WebDriver for the product Profession EHR.
- Contributed to design process, evaluated efforts estimation, conducted reviews, analyzed requirements/user stories and non-functional requirements in a fast-paced and dynamic agile environment.
- Mitigated project risks and reduced 20% in test cycle execution by implementing Risk Based Testing approach.
- Liaised closely with the product management to design Requirement Traceability Matrix (RTM) and Test Plan.
- Prevented recurring failures and reduced risks by performing root cause analysis to identify and address existing
- Work closely with the product management and the development team to get the solution packs qualified for the release.
0-5 years of experience
Managed Quality System Implementation and Improvement on a Surface Mount Printed Wire Board Assembly Line.
- Participated in a Quality Improvement Team addressing customer removal rates on surface mount codes resulting in a 3-month Quality Improvement of 58%.
- Generated support documentation utilized in efforts for Lucent Power Systems to win the Deming Prize for Total Quality Management.
- Performed a Designed Experiment on Printed Wire Board Design Parameters eliminating field reliability issues and manufacturing rework.
0-5 years of experience
Responsible for providing planning and verification for new and existing products through detailed analyzes and evaluation of contracts, specifications and hardware. Managed the review and disposition of all non-conforming parts and products for the purpose of coordinating positive corrective action and resolution of issues.
- Coordinated with Engineering, Purchasing and QC Inspectors on troubleshooting issues related to inspections.
- Participated in the relocation and redesign of the Quality Department. Helped design, improved flow and identification of product by using product flow lines, new ergonomic lift tables for inspection and marking activities.
- Knowledgeable on ISO, API Q1, API 6A & API 6D specifications for the Oil and Gas Industry.
- Created trend analysis reports of non-conformances from both internal and external sources. These reports were communicated to both internal upper management and the corporate office.
- Participated in multiple internal audits and external supplier audits for the purpose of improving both internal and supplier processes.
0-5 years of experience
Successfully implemented the supplier development and approval programs.
- Planned, organized and implemented multiple projects resulting from new orders and/or new product/process development or changes.
- Managed the entire project cycle via cross-functional teams.
- Projects completed on time, at/or below cost to meet or exceed customer requirements.
- Extensive interaction with customers, suppliers and all levels of [company name] personnel.
- ISO 9000 / QS 9000 system development. Developed, implemented and administered the Advance Product Quality Planning, Calibration systems and Supplier Development systems.
- Managed Calibration and Quality Assurance Technicians.
0-5 years of experience
Maintained Quality Operating Systems by assuring overall quality of the product and 100% compliance to both TS and customer specific requirements.
- Prepared PPAP documents; Control Plan, Flow Charts, Process Drawings, PSW’s and PFMEA’s. Interacted with suppliers for Quality feedback on product changes and provided technical assistance.
- Lead critical Supplier quality issues for timely resolution and monitored the effectiveness of incoming quality control system by implementing receiving inspection.
- Managed automotive customer’s quality portals in North America region and improved key quality performance indicators to enhance customer satisfaction.
- Lead Advanced Product Quality Planning activities, Process Changes and Quality improvement plans.
0-5 years of experience
Implemented and executed operations quality requirements to ensure product integrity and compliance during Payload integration, Battery manufacturing, Spacecraft Integration and test
- Processed nonconformance using MES and supported root cause corrective action (RCCA)
- Led employee involvement team focusing on process improvement opportunities
- Supervised daily operation, staff assignments and compliance of all procured hardware within the Satellite Development Center Receiving Inspection & Test (RIT)
- Collaborated with functional groups to determine material dispositions and drive product and process improvements
- Performed random audits to ensure quality standers are in place
0-5 years of experience
Manufacturer of machined components to the Military, Power Generation, and Aerospace Industry
- Provided technical expertise to company employees, suppliers, customers, and regulatory agencies to ensure compliance with government contract; ISO9000/MIL-I-45208A
- Monitored and reported supplier quality related activities to verify Quality System, product, and contract purchase order compliance is established
- Prepared, maintained, and reviewed quality procedures to ensure compliance with customer and/or government requirements
- Programmed Brown & Sharpe CMM with PC-DMIS software for the inspection and certification of machined components
0-5 years of experience
NBHX produces real wood interior trim components for high end luxury vehicles.
- Served as quality engineer for Ford F-150 and BMW X5 programs.
- Coordinated PPAP submissions for respective programs.
- Managed returned goods for customers and suppliers.
- Facilitated the 8D process for internal and external corrective actions.
- Developed customer approved color and boundary samples.
- Reported to the Quality Manager.
0-5 years of experience
At QS 9000/ISO 9000 company, made customer site visits to evaluate and respond to quality issues, improve customer relations, Material Review Board (MRB), document control, PPAP and ISIR, production monitoring and charting of quality performance
- Managed Gage Control for QS 9000
- Established a supplier base system; duties included: management of MRB, customer complaint route and customer return tracking system
- Created defect tracking and reporting system and championed 8D teams
- Developed the Supplier Quality Engineering function responsible in ISIR and Supplier Quoting packaging to conform to the automotive PPAP program
0-5 years of experience
Identified and executed improvements to the quality system in compliance with SQF standards
- Coordinated with production to meet customer releases and operating priorities
- Designed and implemented an electronic non-conforming material tag/line clearance form and database through Excel with VBA coding and macros
- Determined RCA for non-conforming product and reported CA back to the customer
- 5S Pillar Team Leader
10+ years of experience
Created/Maintained Quality procedures for the various product lines
- Reviewed and recommended nonconforming material for disposition as applicable
- Assisted product assessment personnel by performing activities to expedite product assessments
- Worked to the requirements of Quality Systems (MIL-Q 9858, MIL-I 45208, MIL-STD 2000, ISO-9000) specification
- Performed monthly surveys and audits to assure compliance of quality procedures and specifications
- Wrote various procedures and created forms in conjunction with the High Reliability soldering effort (i.e., defect rate analysis, preventive maintenance and process checklist)
- Generated monthly reports, participating member of a Total Quality Improvement Team.
0-5 years of experience
The only Quality Engineer in the Cooking Manufacturing Facility supporting 9 assembly lines and fabrication stamping and forming.
- Developed and Managed Quality projects based on Service Incident Reporting.
- Major projects included the redesigning of all oven and range doors, gas leak testing process and equipment improvement and redesigning the gas wall ovens to improve air flow to eliminate hot customer contact areas.
- Developed process maps for each function in fabrication(hard tooling, soft tooling, welding, metal finishing
- Managed all calibrations in support of the Cooking and Refrigeration facilities.
- Managed the Metrology Lab responsible for all first articles dimensional layout of all internally produced fabricated parts to support new model launches and assembly line issues.
- Currently supporting the launches of 8 new grill products, 3 electric cook top, 2 gas cook tops 2 wall ovens and 3 new ranges.
0-5 years of experience
Created 12 procedures and 70 Work Instructions, including all the receiving inspection instructions
- Responsible for the preliminary validations for a prototype portable export cutter room
- Coordinated quality system auditing and trained receiving inspector
- Maintained control of measuring and test equipment to include calibration scheduling and document control
- Responsible for mechanical precision inspection and resistance testing on selected components and subassemblies
- Directed DOE (Design of Experiments) for production process evaluation
- Established AQL sampling technique management per ANSI/ASQ Z1.4- 2003 Standards
- Chaired the MRB (Material Review Board) & control of nonconforming product
- Assisted with ISO-13485 FDA audit.
0-5 years of experience
Worked with developing a new door panel as a Tier two supplier to GM.
- Developed and analyzed statistical data and product specifications to determine production standards and established proposed quality and reliability levels of finished product.
- Developed and maintained quality customer relations.
- Monitored and evaluated all logistics and maintenance operations to prevent defects/errors and to verify adherence to quality plans.
- Troubleshot inaccuracies or problems in the process and product.
- Operated closely with Production Managers and Supervisors to establish priorities, qualify processes, and effectively address process improvement and quality issues.
- Root cause analysis and implementation of corrective action for process related concerns.
0-5 years of experience
Technology & Operations- RBC QA Team
- 5000+ test cases created, executed, and updated based on the defect process flow.
- 25+ banking modules with business rules, UML diagrams, wireframes, and content created and updated.
- Performed automation testing for mobile applications using Java and Appium.
- Project Sapporo (2015). Native iOS mobile application for Canada’s largest financial institution. Objective-C.
- Project P (2014). Developed a next generation mobile banking application for Canada’s largest financial institution using the Worklite vendor. The application was developed for three mobile platforms: iOS, Android, and Blackberry. HTML, CSS, JS, XML, HPQC, HPQTP, Java.
0-5 years of experience
- Led joint application design reviews & ISO 14971 risk/hazard analysis of modified power connector; comply IEC 60601-1.
- Validated titanium cleaning process; performed IQ, OQ, PQ optimizing response best settings for an Extrude Hone polisher.
- Led the rehearsal for BSI’s internal audit; trained auditees in collecting observations vs. findings; ranked/assigned CAPA’s.
- Examined field returns and partnered with vendors on critical investigations; tended a CA log summarizing aging metrics.
- Revised incoming inspection policies, acceptance sampling Z1.9/1.4 2003 criteria and update ANSI 14.5 GD&T drawings.
0-5 years of experience
Tested home security panels, sensors, thermostats, lights, and locks using Smoke and Regression testing methods to find any bugs or issues
- Reported any bugs or issues to software developers to be fixed
- Updated panel firmware once software developers fixed reported bugs
- Assembled security systems and panels
- Followed test plans and documented the results using Testlink software
0-5 years of experience
Solving Customer concerns by identifying Root Cause and implementation of Permanent Corrective Action in global 8D format and 5 Why’s format.
- Preparing PPAP Package, Part Submission Warrants, Performed Run-@Rates, Operator Instructions, Cell Layouts, Quality Alerts.
- Assisting Quality Manager in Gage R&R and Process Capability study to eliminate process variations
- Wrote detailed work instructions and assisted in training production staff on quality procedures and policies.
- Responsible for training GP-12 team as per (ISO 9001: TS 16949) standards on in house inspection for any production defects. Also maintaining and analyzing daily scrap production for further improvements.
- Responsible for updating DCP’s and FMEA’s for any Engineering and Process change.
- Conducting weekly QPR meetings to discuss critical quality concerns with higher management.
0-5 years of experience
- Managed Compliance ISO 9001: 2008 Policies, Procedures and Work Instructions.
- Developed and implemented a system for trending production and performance quality system levels.
- Coordinated troubleshooting of component defects and quality issues pursuing resolution with Process engineer, product engineer, test engineer and supplier quality engineer.
- Responsible for weekly, monthly & quarterly analysis reports. Reports were created in Excel using various functions like V-Look ups, Index Matching, Pivot Table, etc.
- Responsible for customer satisfaction; Conducted weekly meetings with client to provide statuses and detailed analysis on the expected metrics.
- Developed a database to reduce and to track customer returned rate.
- Performed 5S audit and ISO audit for the company.
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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.
