Quality Systems Engineer Resume Samples

A Quality Systems Engineer is hired to conduct frequent and detailed quality checks and ensure that the products and processes in the manufacturing setting are consistent and meets the client and industry standards. Several duties associated with this role are listed on the Quality Systems Engineer Resume as – providing support for product assurance from design effort to initial product qualification; interacting with production and engineering personnel to setup production test requirements; reviewing test plans and methods relating to quality systems; establishing crucial product characteristics and performance metrics; providing process capacity analysis and preparing processes to promote feedback and corrective actions; supporting production readiness review efforts, and assisting in the development of work instructions.

Summary of skills often expected include – work experience, profound knowledge of statistical process control and reliability analysis; familiarity with test procedures; sound knowledge of quality system development, supplier quality, process development; steep knowledge of basic statistical concepts, and thermal night vision technology; and statistical skills. A relevant engineering degree is commonplace among job applicants.

 

Quality Systems Engineer Resume example

Quality Systems Engineer Resume

Summary : Quality Systems Engineer with +15 years work experience in manufacturing plants applying the ISO 9001, ISO/TS 16949 OHSAS 18001, ISO 13485, (QSR & CFR), VDA & Ford Q1 standards and the skills to drive business growth and manage all aspects of daily business operations throughout the follow up to applicable documentation and internal (system & process) audits.

Skills : MS Office, Management Skills, Communication Skills.

Description :

    1. Led Internal auditors group - Ensure VDA 6.3 requirements aligned to our Quality system in order to comply with corporate requirements.
    2. Led Management Review (development and carry out presentation) including KPI's, all ISO standards applicable to the organization & legal/corporative requirements as well as the follow up of open action items.
    3. Worked with all areas of the organization to develop and implement Ford MP&L and MMOG, towards the Q1 certification, update Ford portals (CQI, MSA, Contacts, Certificates, etc.).
    4. Recorded Control management to comply with required disposition on ISO to standards.
    5. Established and followed up on internal process audits (LPA) as per CQI-8 and customers' requirements.
    6. Developed and performed ISO introduction to all new hires at all levels of the organization.
    7. Led Quality Management System documentation processes, including the master document control list, and lead the review, approval, distribution, and training of new or updated procedures.
Years of Experience
Experience
10+ Years
Experience Level
Level
Senior
Education
Education
GED


Quality Systems Engineer Resume

Objective : Quality Systems Engineer with 1 year of experience in Engaging in Corrective Action and problem-solving activity. Participates in brainstorming and implementing agreed-upon improvement plans.

Skills : ASQ Certified Six Sigma Black Belt, ASQ Certified Quality Engineer.

Description :

    1. Included the issuing, review, and verification of corrective actions both internal (Corrective Action Requests) and external (Supplier Corrective Action Requests).
    2. Included working with the Engineering department on validations conducted on new/changes to processes involved in the manufacture of medical devices.
    3. Included performing vendor audits, reviewing vendor surveys and attend vendor visits.
    4. Analyzed and closed customer complaints on returned products.
    5. Included trending, charting, reporting and initiating corrective action.
    6. Trained, coached, and aided the cross-functional team in the creation and maintenance of procedures, work instructions, forms, and other documentation in accordance with ISO9001/ISO13485 standards.
    7. Administered the internal audit program and host external audits (ISO, FDA, Customer, etc.) for the North American business.
Years of Experience
Experience
0-2 Years
Experience Level
Level
Entry Level
Education
Education
Diploma


Quality Systems Engineer Resume

Summary : Quality Systems Engineer with more than 10 years in areas related in manufacturing, biotechnology, pharmaceutical and construction industries. Experience in documents development, documents execution, documents review and data verified. Experience in Commissioning and Qualification of Equipment and Utilities.

Skills : MS office, Creative Skills, Multitasking.

Description :

    1. Created new Change Orders and approved documents and/or Change Orders.
    2. Revised, reviewed, & approved different SOPs (Standard Operating Procedures) either to create, redline or expire/deactivate an SOP in Fenwal's system.
    3. Helped transition Warrendale to Fenwals SOPs & assign required training for each role.
    4. Created a new form for Warrendale to use when there are product complaints.
    5. Led weekly meetings via conference calls to communicate changes or updates on forms & SOPs for Warrendale to use.
    6. Created a spreadsheet of a gap analysis on pending change orders that are still open, have issues, or that can be closed.
    7. Supported the Global Chemicals sales team with technical expertise and supply chain data for product related or process related inquiries.
Years of Experience
Experience
10+ Years
Experience Level
Level
Senior
Education
Education
BS

Quality Systems Engineer Resume

Headline : Responsible for Extending the reach of the Central Quality Organization in the continued journey to develop a sustainable quality culture at the plant level by supporting site resources using a collaborative and proactive approach.

Skills : Developing Skills, Quality System Skills, Multitasking.

Description :

    1. Handled customer audits, customer feedback, respond to the root cause, and corrective action requests from customers (Boeing, LMI, Magellan Aerospace, Sikorsky Aircraft, Curtiss Wright, GKN, Glencoe).
    2. Handled all customer shipments to assure all documentation required is present with hardware being shipped.
    3. Created company certificate of conformance for each shipment.
    4. Reviewed all outside services purchase orders for accuracy and to make sure all customer requirements are flowed down to suppliers.
    5. Rewrote entire company, AS9100 Rev.
    6. Drive a systematic approach to quality improvement efforts including root cause analysis and corrective action implementation.
    7. Coordinated and trained employees in quality compliance standards.
Years of Experience
Experience
5-7 Years
Experience Level
Level
Executive
Education
Education
GED

Quality Systems Engineer Resume

Objective : To establish a long-term career in a company where I may utilize my Quality Systems Engineer professional skills and knowledge to be an effective Quality Systems Engineer and inspiration to those around me.

Skills : Planning SKills, Team Work, Leadership.

Description :

    1. Traveled to component supplier facilities, performed quality surveillance audits, error proofing services, and made recommendations for improvements.
    2. Performed follow up and accepted corrective action reports to ensure completeness.
    3. Provided upper management with industry trend information and suggestions for implementation including cost analysis.
    4. Conducted source inspections when needed using blue line drawings.
    5. Responsible for the accuracy, storage, and retrieval of regulatory documents including weight and balance reports, return to service logbook entries, and support engineering information.
    6. Provided regulatory training to company employees in Texas, Wisconsin, and Connecticut.
    7. Inspector Performed incoming, in-process, first article, and final inspections on airframe and power plant repairs, alterations, and modifications.
Years of Experience
Experience
2-5 Years
Experience Level
Level
Executive
Education
Education
BS

Quality Systems Engineer Resume

Objective : Highly qualified Quality Systems Engineer with experience in the industry. Enjoy creative problem solving and getting exposure to multiple projects, and I would excel in the collaborative environment on which your company prides itself.

Skills : Microsoft Office, Project Management, ISO 9001.

Description :

    1. Assisted in new product introduction for project definition of tasks and ownership of actions for completion of work instructions, PFMEA schedule, and control plans; as needed.
    2. Maintained NCM database, communicate reported NCM's to suppliers for corrections and dispositions of NCM product; facilitate MRB review boards for disposition of the suspect product.
    3. Reviewed incoming PPAP documents and direct as required to responsible parties.
    4. Maintained PPAP acceptance database for each product line.
    5. Consolidated, reported, updated internal metric boards for Safety, Quality, Cost, and Customer Satisfaction.
    6. Provided professional recommendations for refinement of each internal metric.
    7. Trained employees on new and existing processes.
Years of Experience
Experience
2-5 Years
Experience Level
Level
Junior
Education
Education
GED

Quality Systems Engineer Resume

Objective : Quality Systems Engineer with 4+ years of experience in Participating in training and coaching site resources in quality systems and compliance issues, Serving as local quality compliance liaison with corporate compliance organization.

Skills : MS Office, Six Sigma Black Belt, Creative SKills.

Description :

    1. Certified Green Belt Certified ISO/TS16949 RABQSA Lead Auditor Trained in Core Tools Performs Managerial Duties/Responsibilities in Quality Manager's Absence Tracks Customer Score Cards on a Daily Basis for Big 3 Customer Portals: GM, Ford, and FCA.
    2. Tracked Customer Complaints and Problem-Solving in the same systems to ensure timely processing of Corrective Actions.
    3. Tracked and updated KPI's for the entire organization each month that align with the Business Strategy.
    4. Trained all employees on the new system.
    5. Designed and implemented a Records Management System at GKN that meets ISO and Customer Requirements.
    6. Redesigned and Launched an Intranet based system from which all Level 1, Level 2, Level 3, and Level 4 documents can be accessed.
    7. Developed and maintained training flex charts per area, by the team for cross-training requirements.
Years of Experience
Experience
2-5 Years
Experience Level
Level
Executive
Education
Education
BS

Quality Systems Engineer Resume

Objective : Responsible for Conducting Business Management System Internal Audits per the ENA Audit Schedule, and also driving the sites to a state where the quality system is continuously sustainable.

Skills : Autocad, STAAD.Pro, Limcon, Matlab, Excel.

Description :

    1. Developed and maintained the Quality Management System of the organization with respect to the ISO 9000 family, ensuring its implementation within various departments and locations across GCC.
    2. Developed a strong capability for the organization against ISO and other standards.
    3. Facilitated in better alignment of the organization towards international quality standards by conducting ISO 9001 Internal and External Audits.
    4. Facilitated the project locations in better performance in quality aspects.
    5. Maintained all the necessary documents and records of all the offices and project locations across GCC.
    6. Determined and initiated the need for additional Quality System Procedures (QSP's).
    7. Identified and maintained a matrix of Quality records to demonstrate compliance with the quality system.
Years of Experience
Experience
2-5 Years
Experience Level
Level
Executive
Education
Education
MS

Quality Systems Engineer Resume

Objective : Seeking a Quality Systems Engineer position with an outstanding career opportunity that will offer a rewarding work environment along with a winning team that will fully utilize management skills.

Skills : Six Sigma, Manufacturing, Compliance, Customer Service, Operations Research, Research And Development, Adverse Events, Field Actions, RGA, IPC 610.

Description :

    1. Developed food safety qualification plans to successfully integrate new processes, equipment, line installations, and products.
    2. Managed regulatory, religious, and 3rd party audit certification(s): FDA, Kosher, Halal, and GMP/Food Safety.
    3. Established and validated CIP processes and SSOPs on all processing equipment.
    4. Designed microbiological challenge studies to validate the food safety properties of Torani Syrup formulas.
    5. Conducted extensive allergen assessment study on all allergenic raw materials and finished products.
    6. Investigated issues found in Raw Materials, WIP (Work in Process), Finished Products, Customer Complaints.
    7. Performed Mock Recall/Traceability exercises to trace all products within 2 hours.
Years of Experience
Experience
2-5 Years
Experience Level
Level
Junior
Education
Education
GED

Quality Systems Engineer Resume

Objective : To obtain a challenging Quality Systems Engineer position where I can maximize my leadership, quality, and inspection strengths and abilities as well as expand my knowledge in quality system procedure development, training experience, and analysis of company metrics.

Skills : Microsoft, Organizational Skills, Creative Skills.

Description :

    1. Developed and implemented statistical process controls as needed using appropriate quality tools and statistical techniques.
    2. Developed positive relationships and effective lines of communication with all functions, suppliers, and customers.
    3. Developed, monitored, reported appropriate and effective metrics that monitor the effectiveness of assigned processes.
    4. Verified customer QA inspection requirements for all products delivered are being followed with accurate, thorough, and complete inspection records.
    5. Assisted Quality Manager with supervising and training needs of quality staff as needed, mentoring personnel to enhance development and growth.
    6. Ensured regulatory compliance in all International countries where Torani was sold.
    7. Facilitated all customer audits and Corrective action reports.
Years of Experience
Experience
2-5 Years
Experience Level
Level
Junior
Education
Education
BS