LiveCareer-Resume

quality engineer resume example with 12+ years of experience

Jessica Claire
  • , , 609 Johnson Ave., 49204, Tulsa, OK 100 Montgomery St. 10th Floor
  • H: (555) 432-1000
  • C:
  • resumesample@example.com
  • Date of Birth:
  • India:
  • :
  • single:
  • :
Professional Summary

Relentless Supplier Quality Engineer with 5 years working alongside supply chain participants to maintain superior production resources. Maintains strict adherence to extremely high supplier standards without alienating business partners. Adept at helping manufacturing allies enhance contributions through judicious application of remedial advice and financial encouragement. Consummate supplier Quality Engineer ready to guard against variances and flaws in supply chain contributions. Comfortable verifying manufacturing components and human resource competencies. Provides timely and actionable intelligence on supplier performance. Safeguards smooth and uninterrupted company operations by maintaining mutually beneficial supplier relationships.

Skills
  • ISO 9001 standards
  • Materials review
  • Quality Improvement Plans
  • Process Change Documentation
  • Non-Conforming Materials Process
  • Root Cause Analysis
  • FMEA Certification
  • Corrective Actions
  • Testing Protocols
  • Validation Master Plan
  • Equipment Calibration
  • Audit Planning
  • Job requirement analysis
  • Statistical Methods
  • Design
  • Excellent Communication
  • Attention To Detail
  • Working With Vendors
  • Government Compliance
  • Processes And Procedures
  • Employee Safety
  • Internal Audit
Work History
Quality Engineer, 09/2022 - 02/2023
Allscripts New York, NY,
  • Experienced with Batch record, quality incident reporting and daily record update and activates of material review Board(MRB).also review of non conformance material(NCMR).worked and supported in team with Material Review Board(MRB) and non -conforming report activity in QA and QC department
  • Also solve problem with supplier material in incoming quality department and production NCR MRB activates(Internal and external for material on hold due to NCR and QI ).work directly with QI owner, NCMR Owners and resolved NCR TO CLOSURE
  • Operational Quality Risk Assessment processes to help reduce process deviations
  • Input and maintenance of databases for Complaints and nonconformance reports (NCRs), MDR Sheets, SCAR(s), MEDWATCH, CAPA(s), Document Change Control,
  • Experienced and worked with planning, production, operations,engineering,product engineering for MRB activites.also experiences working with supplier Quality,quality Engineering,quality control and maintained up to date status and disposition plans for all materials on hold.comunicated with material supplier customers on every day for updates on all
  • Contributed to root cause analysis to determine core reason for failures and errors
  • Trained and mentored junior engineers, providing guidance and direction
  • Assisted in developing cost-effective solutions to engineering problems
  • Coordinated with quality control staff to complete inspections
  • Performed quality inspections and drafted reports to detail non-conforming material issues.
  • Supported quality team members during corrective action updates.
  • Contributed to root cause analysis to determine core reason for failures and errors.
  • Coordinated with quality control staff to complete inspections.
  • Analyzed issues with supplier contributions to detect defect trends, reporting findings to appropriate personnel
  • Drafted instructional documentation for distribution to suppliers to establish standardized performance and quality thresholds
  • Led commodity-related quality control issues, correcting functional issues stemming from problematic components
  • Maintained amiable relationships with suppliers through difficult quality control issues, supporting healthy business interactions
  • Aided suppliers in raw material selection strategies to encourage superior supply chain outcomes
  • Traveled to assigned supplier facilities to verify supplier staff qualifications via multiple modes of inspection and investigation
  • Provided capability assessment and testing for individuals and teams assigned by suppliers
  • Designed inspection plans and methods for execution by personnel at remote locations, verifying accurate implementation and data collection
  • Resolved supplier quality control issues through collaboration with third-party leadership
  • Reduced downtime and increased production capacity with strong maintenance plans
  • Collaborated with cross-functional teams to develop and implement process changes
  • Developed and implemented process improvements to reduce costs and increase efficiency in industrial production
Quality Engineer, 06/2022 - 08/2022
Allscripts Philadelphia, PA,
  • NCMR's and MRB Material and disposition plan with QC staff, Material Handlers, warehouse employees and liaison to various functions with different department in organization
  • Supported quality team members during corrective action updates
  • Contributed to root cause analysis to determine core reason for failures and errors
  • Reported on non-compliance issues and other negative factors discovered during production
  • Coordinated with quality control staff to complete inspections
  • Performed quality inspections and drafted reports to detail non-conforming material issues
  • Maintained compliance with industry standards and regulatory compliance during managed projects
  • Reported on non-compliance issues and other negative factors discovered during production
  • Developed and implemented comprehensive quality assurance program to guarantee organization products met safety and quality standards
  • Developed action plan for company certification using ISO 9000 standard knowledge
  • Facilitated process improvements to successfully decrease errors
  • Developed traceability documentation to aid in investigating faults and defects
  • Contributed to root cause analysis to determine core reason for failures and errors
  • Supported quality team members during corrective action updates
  • Performed quality inspections and drafted reports to detail non-conforming material issues
  • Coordinated with quality control staff to complete inspections
  • Led problem-solving activities to quickly identify and permanently resolve quality and productivity issues
  • Maintained compliance with industry standards and regulatory compliance during managed projects
  • Partnered with senior management to analyze issues and find appropriate solutions
  • Researched and evaluated new techniques and technologies to improve product quality
  • Developed and implemented comprehensive quality assurance program to guarantee organization products met safety and quality standards
  • Facilitated process improvements to successfully decrease errors
  • Executed operational audits and assessed company operations, compliance and other associated risks
  • Reported on non-compliance issues and other negative factors discovered during production
  • Escalated concerns about project and process quality, referring discovered issues to engineering manager for correction
  • Developed traceability documentation to aid in investigating faults and defects
  • Developed action plan for company certification using ISO 9000 standard knowledge
  • Recommended revisions to internal controls and operational and management policies and procedures
  • Conducted technical evaluations of engineering designs and test results.
  • Computerized office activities, maintained customer communications, and tracked records through delivery
Quality Engineer, 10/2010 - 06/2022
Allscripts Seattle, WA,
  • Coordinate all activates pertaining to ISO 9001 and ISO 13485 quality management system and FDA21 CFR820 quality systems regulation, including continuous improvement and quality assurance
  • Monitor non-conforming material in the plant and prepared weekly reports on the status of rework inventory, ERP updates, and documentation
  • Performed process and product, and system audits, communicating quality issues with employees and management
  • Coordinated process troubleshooting efforts with engineering
  • Completed activities related to customer complaint process and CAPA investigation and follow-up
  • Performed internal audits for ISO-9001 and ISO 13485 QMS also issued CAPA timely closer
  • Maintained training records in ERP including job the job description actively
  • Experienced and used measuring tools like DGT AND CMMR, root cause analysis, corrective action, and poke yoke
  • CAD ,design and GDT,tolerance stack analysis, tool room environment and CMM principles
  • Box G
  • P validation Accelerated validation with regular testing (software secured validation used to check contamination of material using software secured validation
  • Iron graph and material hardening tester.)
  • Resolved problems by analyzing data, investigating issue, identifying solutions, and recommending actions
  • Coordinated and interacted with head and department lead to understand process and documentation
  • Utilized gage calibration systems repair or replaced gages as needed
  • Prepared PPA (production parts approval process for new products as needed
  • Monitored supplier performance and conduct supplier audits and maintained training records
  • Supported quality systems process to maintain quality system compliance and effectiveness throughout the value stream from supplier through design/manufacturing and to the customer
  • Experienced with lead quality systems process including MRB/DMR, RMA, CAPA, and internal audit and collaborated with members of the AQR team members of company
  • Strong computing experiences with ERP, customer, supplier, and regulatory portals
  • Coordinated with quality control staff to complete inspections
  • Supported quality team members during corrective action updates
  • Contributed to root cause analysis to determine core reason for failures and errors
  • Performed quality inspections and drafted reports to detail non-conforming material issues
  • Researched and evaluated new techniques and technologies to improve product quality
  • Led problem-solving activities to quickly identify and permanently resolve quality and productivity issues
  • Partnered with senior management to analyze issues and find appropriate solutions
  • Researched and evaluated new techniques and technologies to improve product quality.
Education
Bachelor of Science: Electrical Engineering, Expected in 12/1988
-
M.S.University of Baroda - Vadodara,India,
GPA:
Status -
Certifications
Sun Certified System,

By clicking Customize This Resume, you agree to our Terms of Use and Privacy Policy

Your data is safe with us

Any information uploaded, such as a resume, or input by the user is owned solely by the user, not LiveCareer. For further information, please visit our Terms of Use.

Resume Overview

School Attended

  • M.S.University of Baroda

Job Titles Held:

  • Quality Engineer
  • Quality Engineer
  • Quality Engineer

Degrees

  • Bachelor of Science

By clicking Customize This Resume, you agree to our Terms of Use and Privacy Policy

*As seen in:As seen in: