Quality System Engineer Resume Sample
Kaylin Casper
8141 Mario Hollow,
New York,
NY
+1 (555) 603 6861
Work Experience
Senior Quality System Engineer
02/2018
-
PRESENT
Houston, TX
- Assist Global Quality Manager and Regional Quality Leaders in development of key AQH business processes
- Create and execute training plans and materials for key global business processes (APQP, etc)
- Execute annual internal audit plan in accordance with requirements for ISO9001 standard
- Deliver training for internal auditors
- Drive closure of corrective actions – customer complaints, internal/external audit findings
- Where findings require documented follow-up, create and maintain records of Corrective Action in keeping with ISO / BPMS procedures
- Assist in publishing and updating of Policies, Business Processes, work instructions, and forms as required to maintain compliance with ISO 9001 standard, Agency requirements and AQH specific requirements
Quality System Engineer
07/2012
-
11/2017
Boston, MA
- Experience in Quality Systems management. Be familiar with manufacturing process
- Expert in quality control tools and solid understanding of Quality Systems and related requirements
- Experience in conducting internal audit and handling customer audit
- Strong interpersonal and communication skill in working with cross-functional teams
- Strong communication skills and history of influencing at all levels of an organization. Negotiation skills
- Eager to learn, can do attitude and good problem solving skill
- Work closely with technical staff and/or outside resources to determine technical solutions and/or applications to meet the identified requirements
- Support users to solve software issues such as missing data or incorrect data in SPC database, Suppliers COA upload failures, Customer CofA generation failures, CofA template changes, etc.
Geoint Product Quality System Engineer
05/2009
-
01/2012
Philadelphia, PA
- Ensure instruments and machines are communicating with software and data is available in SPC database
- Work closely with users on the appropriateness of the process control charts and evaluate the maturity of the charts and drive towards higher maturity level on a periodical basis. Example: assist/advise in setting up charts, make changes or update charts properties
- Support software and hardware new installation or upgrades. Example: rolling out new camLine versions or replace camLine server
- Perform integration and testing for Input CofA from suppliers and output CofA to Customers
- Maintain and updates documents related to SPC system software
- Educate users of the software tools. Conduct training for SPC, SQM, CQM and Stargate system modules
- Participate in risk analysis in Product / Process Design and collaborate in mitigation plan development
Education
Wittenberg University
2004 - 2009
Bachelor's Degree in Engineering
Professional Skills
- Innovative, with excellent judgment and problem solving skills
- Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues
- Strong computer skills, including MS Word (advanced user), Excel, Visio, and related MS Office applications
- Posses strong analytic and problem solving skills
- Position requires substantial experience and skills to support the routine use of MS Excel, PowerPoint, and Minitab
- Experience managing team projects, including experience as an active contributor on projects with scheduled deliverables
- Good team working spirit and communication skills
How to write Quality System Engineer Resume
Quality System Engineer role is responsible for english, training, teamwork, manufacturing, integration, database, auditing, reporting, design, assembly.
To write great resume for quality system engineer job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Quality System Engineer Resume
The section contact information is important in your quality system engineer resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Quality System Engineer Resume
The section work experience is an essential part of your quality system engineer resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous quality system engineer responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular quality system engineer position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Quality System Engineer resume experience can include:
- Initiative, communication and writing skills
- Prior experience in
- Manage and interface effectively with teams
- Working experience with ISO 13485 and with medical device regulations (i.e. MDD 93/42/EEC, FDA 21 CFR Part 820)
- Experience in auditing techniques as well as interpreting and transforming requirements to practical implementation
- Facilitate improvements of the QMS and provide training in QMS and Good Manufacturing Practices (GMP)
Education on a Quality System Engineer Resume
Make sure to make education a priority on your quality system engineer resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your quality system engineer experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Quality System Engineer Resume
When listing skills on your quality system engineer resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical quality system engineer skills:
- Good communication skill, strong teamwork spirit, positive attitude
- Very good presentation skills for internal and external audience
- Good written and oral English skill.Good team work spirit, be responsible,self-driven and target
- Good communication and coordination skills both in Chinese and English , team player
- Good communication skills, both written and oral in English
- Drive and “problem solving” skills
List of Typical Experience For a Quality System Engineer Resume
1
Experience For Senior Quality System Engineer Resume
- Attention to detail with good understanding of the big picture
- Assists management teams to ensure timely closure of audit observations. Lead non-conformance investigation teams to identify root causes and effective CAPAs
- Relevant technical and/or program management experience
- Experience within quality/compliance for medical device or similar FDA-regulated industry
- Manage transition plans for evolution of development tools (planning, training, coaching) as applicable to quality function
- Support Offer and Project Quality Managers for improving of Quality Metrics and KPIs
2
Experience For Senior, Quality System Engineer Resume
- The Quality System Engineer (NQA-1, ISO9001) plans activities concerning the development, application, and maintenance of quality processes
- Assist in company preparations for hosting external audits
- Conduct routine audit and checking to ensure quality systems requirements are implemented and the procedures are followed closely
- Contribute to the Project Quality Plan definition and Project Quality Goal setting
- Ensure that the Product quality is built & maintained in their design to ensure improved customer satisfaction
- Contribute to the Project Quality Plan definition and its execution
- Execute quality actions of PEP and monitor PEP execution and completion through PCR/PCN tasks
- Performance Data management for Offer & Project Quality
- It is your duty to support the Quality Director in getting through the certification process aiming to obtain the required certificates and makes sure that the company fulfils the requirements of quality standards in different geographical areas
3
Experience For Global Quality System Engineer Resume
- Act as Internal Auditor according to audit plan
- Perform Process and System Improvements
- External Audits, be part of preparation, execution and follow up
- CAPA Process, locally responsible for the CAPA Process and provide support to the organisation
- Be part of Design Reviews when needed
4
Experience For Geoint Product Quality System Engineer Resume
- Document Control, provide support to the organisation
- Assure compliance with corporate and divisional requirements regarding metrics reporting for the Management Controls / Management Review and CAPA quality systems
- Assure the collection, compiling, reporting and dissemination of key quality and compliance metrics/data are completed within the requiring timing
- Complete trend analysis of data as appropriate to ensure proper actions can be determined or assessed
- Perform and assure timely follow-up activities in support of key quality and compliance metric/data goals and policy/procedural requirements
- Develop and provide data and analysis in support of Management Controls / Management Review and CAPA Quality Systems
- Identify opportunities to apply, continuously improve, and redefine quality systems and controls product-related processes in accordance with applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc
5
Experience For Quality System Engineer Steel Piston Resume
- Represent Quality Systems as required in support of cross-functional projects
- Participate in external and internal audits
- Lead, coach, and mentor non-exempt and entry level exempt personnel on quality principles and procedures
- Function as part of risk assessment teams to identify product, quality system and compliance requirements
- Function as part of special project teams to identify compliance gaps and develop and execute strategies to close gaps
- Serve as primary interface and contact for FAA, Customer and/or 3rd party quality system compliance audits. Follows up on corrective actions regarding non-compliances
- Experience in Quality systems as an engineer
- Coordinate subsequent surveillance audits performed by the Registrar
- Develop and maintain compliance matrices for regulatory, and customer requirements and assist with the creation and implementation of corrective action plans
6
Experience For Vmware Quality System Engineer Resume
- Support the content owners to maintain the relevant section update (check content, up-load of new and update content on the intranet page)
- Prepare and coordinate 2nd / 3rd party system audit
- Coordinate, consult and follow up correction of opens issues from internal and external audits
- Collect and monitor quality KPIs on monthly base
- Tasks that are for the benefit of Brose which are assigned by Manager
- Lead and manage projects associated with site quality initiatives to assure that the distribution center’s interests are accurately and objectively represented from a quality perspective
- Work with peers within Milford and across Waters’ sites to improve and harmonize change management processes
7
Experience For Quality System Engineer, Shanghai Resume
- Work across Waters’ sites to harmonize and improve Quality System processes
- Works with individual departments to help them create process documentation that complies with the company’s standards
- Review Audit Non-conformances (NC’s) and Opportunities for Improvement (OFI’s) with the applicable Departments
- Review responses and determine if stated Root Cause(s) and Corrective Actions are adequate to address the NC’s and OFI’s
- Document management and QMS: the target is to manage document management system activities at global and SBE level and to provide support to all other DSS sites
- Electronic document management system (eDOC): the target is to be the global and SBE system administrator, to manage the global implementation of improvement opportunities together with our external software provider, the DSS sites and DIT and to support in DSS site’s related troubleshooting activities
- Audit management: the target is to perform and manage global audits, to manage global certification audits together with our external certification body and to manage customer audit activities at global level
- ISO/IATF Compliance: the target is to achieve and maintain global compliance with the document and audit management requirements of all applicable international standards and to assist all DSS sites with the interpretation and understanding of these standards
- Manage and improve the CAPA process acting as the site’s CAPA coordinator
8
Experience For Quality System Engineer Resume
- Champion the implementation of QMS tools and technologies to enhance compliance to current standards, regulations and Corporate requirements
- Contribute to and execute a strategy for the implementation of QMS initiatives
- Drive initiatives to improve usability of QMS procedures and instructions
- Manage the Internal Audit process
- Host and follow up on notified body audits
- Project manager/representative on implementation of new eQMS activities
- Manage current paper and eQMS systems
- Support internal functional partners and ensure that all aspects of the QMS are understood, implemented and maintained
9
Experience For Senior Quality System Engineer Resume
- Work closely with all personnel to ensure that aspects of the QMS are understood, implemented and maintained
- Ensure the internal management and control of documents received from customers, via customer portals or emails
- Provide support in the change management process within the automotive segment to ensure that all relevant customer documents are properly handled
- Provide support for quality relevant questions and subjects related with APQP process
- Support in the creation of a document management system for new product development
10
Experience For Senior, Quality System Engineer Resume
- Support and interface with different departments into the organization for topics linked to customer documents management
- Establish, improve and maintain quality procedures for regulatory compliance and process improvement
- Provide quality awareness trainings to new employees
- Monitor and follow up CAPA status, summarize CAPA and reports the trends to the managements
- Assist in external audits, such as CFDA audit, Home Division audit; Notified Body audit, customer audit. Follow up external audit findings
- Knowledge of medical device regulations, such as GMP, GSP, QSR, MDD
- Maintain and improve quality documents on internal website
List of Typical Skills For a Quality System Engineer Resume
1
Skills For Senior Quality System Engineer Resume
- Chinese native speaker and good general English skills (mandatory)
- Good experience in conduct company quality system implementation
- Professional behavior, communication and cooperation skills
- Communication skills both internal (departments) and external (customers and third party)
- Proven history in implementing & maintaining certification to various system standards like ISO9001, ISO14001 etc. in fast paced technology industry
- Quality management working experience in manufacturing plant,, communication and
- Good quality system understanding, systematic thinking method
- Min.5 years working experience in auto components manufacturing industry on quality system side
- Experience with change management and influencing corporate culture
2
Skills For Senior, Quality System Engineer Resume
- Excellent team player and enjoys working with cross-functional team on common goals
- Strong working knowledge of GMP’s, GLP’s, GDP and FDA regulations
- Experience in boosting Ford Q1 MSA and GM QSB
- Good understanding about quality requirements in automotive industry (VDA, QSB, Q1, etc.)
- Locally manages plan for all QMS parts in scope while maintaining compliance and effectiveness throughout the duration of the transition to the PQMS
- Coordinate performance of internal audits with internal auditors including the corrective action process, verification, close out and effectiveness metrics
- Experienced with consulting external regulations and standards in order to recommend and take actions
- Excellent capacity to listen
3
Skills For Global Quality System Engineer Resume
- Experience in quality system management in the automotive industry
- 3+years quality system management working experience in manufacturing plant, customer-oriented
- Offer acceptance and approval prior to release either via PMP or PEP (First Article Inspection) and lead corrective actions as applicable
- Above quality experience
- Be familiar with quality tools, and good statistical analysis ability
- Experience in a similar position
- Skilled in TS16949 or IATF16949, certified internal auditor by qualified corporation
4
Skills For Geoint Product Quality System Engineer Resume
- More than 5 years of experience in similar role in technology industry
- Demonstrated capability to handle multiple tasks and assignments simultaneously
- Internal and External Audit experience
- Experience as Quality System Specialist
- Experience in quality IATF16949 system setup and maintain, and improvements
- Quality related working experience in Medical Device or pharmaceutical company
5
Skills For Quality System Engineer Steel Piston Resume
- Excellent ability to write documents and describe processes and procedures
- Coordination of the internal review and validation (approval) of customer documents within Datwyler
- Organize internal audits to evaluate the suitability, adequacy and effectiveness of the Quality Management System
- Assist company level quality data collection and QOS report consolidation
- Good knowledge of FEMA,8D Metrology, Program & Process Management
- Good knowledge of quality systems
6
Skills For Vmware Quality System Engineer Resume
- Understanding of business processes,
- Acting the CI coordinator to develop CI
- Acting the customer quality engineer
- Working knowledge of GMP’s and other FDA regulations
- Planning of system and analysis places for QM, creation of test routines, test strategies
- Following and support local PQSR for other process standardize progress
- Following and support MMWH &MMCC for plant level quality system
- Tracking the corrective action of audit findings
- Professional qualification on total quality management (TQM), quality engineering and auditing (internal and external)
7
Skills For Quality System Engineer, Shanghai Resume
- Serve as primary resource for training internal auditors and conducting internal audits to ensure adherence to the quality management system, as required
- Maintain plant process management system, including, process system manual, procedure, working instruction and records
- Assist quality training courses and coordinate with HR for quality training for employee
- BS in Electrical or Electronic engineering or equivalent educational background
- Knowledge of quality tools and techniques including, SIPOC,8D(8 Disciplines), SPC (Statistical Process Control), etc
8
Skills For Quality System Engineer Resume
- General understanding of automotive business and its relevant requirements
- Maintain AS9100 Quality System at all Air Cruisers facilities including documentation at all levels
- Support QMS activities at other Zodiac Aerospace facilities as required (requires traveling)
- Issue on defined scheduling the reports related to document management process; support in documents preparation (layout, up-load in eDOC system)
- Plan and perform QMS & EMS internal audit, prepare management review according to ISO/TS 16949 & ISO14001 and Brose specific definition
9
Skills For Senior Quality System Engineer Resume
- Capable of coordinating large scale meetings with both a live and online audience across multiple levels of the organization
- To advise the management team on the status of Schneider Electric’s Quality System and efforts that are being implemented to improve our Quality Systems
- Ensure responses to NC’s and OFI’s meet Audit Timing
- Budget planning for 0km analysis group
- Involvement in integration test cases and test data preparation for functional testing
- Industrial electronic product automotive manufacturing environment
- Enhance and maintain the Business Management System (BMS) to ensure that the system is aligned to business needs and is adding value
- Define and execute ongoing BMS assessment program to proactively drive process improvement
- Ensure that all improvement opportunities arising out of internal or external assessment are addressed in a timely manner
10
Skills For Senior, Quality System Engineer Resume
- Work with employees at all levels of the organization to identify potential process improvement projects, including the business case and project plans
- Responsible for the annual process audit plan, and implement the audit according to the plan
- Coordinate and arrange internal training for updated documentations
- Quality system training base on request
- Knows theory of Parts Measurement, Gage Calibration & Management, PVS & PVI, System Quality and V-Cycle, Specification Understanding, Product Knowledge
- Software Engineering changes
- Proficient in using PC software
- Build awareness for Asia /SEA region through training / communication on current or new quality system concepts and tools
- Support Production, Industrialization and Quality team for project as well as released for manufacturing products improvements
List of Typical Responsibilities For a Quality System Engineer Resume
1
Responsibilities For Senior Quality System Engineer Resume
- Ensure BOS documents are properly revised, approved, released and distributed
- Maintain the web page for the Quality Group
- Implement internal quality system audit, provide internal audit report and follow up corrective actions to be completed
- Support plants or new projects for 3rd party audit and customer audit
- Support new plant quality system set up
- Support APQP and keep customer PPAP records
- Define and maintain the Quality Management System structure to ensure compliance to Philips Policies, ISO 9001, ISO 13485, 21 CFR 803, 806 and 820, cGMP’s, GLP’s, Canadian Food, Drugs Medical Devices Regulations (CMDR)and EU Medical Device Regulations
- Identify and execute recommended quality improvements
- Train and mentor QMS stakeholders owners in all required elements and best practices of QMS processes
2
Responsibilities For Senior, Quality System Engineer Resume
- Manage Remediation activities associated to improve site compliance
- Manage PQMS/PEPF related deployments and implementations
- Support software implementation issues on production
- Cross support with subsidiaries
- Support of 0Km diagnostics
- Analysis of system place failures
- Prepare reports, distribute to project team and conduct defect meetings
- Electronic diagnostic on automotive ECU’s
3
Responsibilities For Global Quality System Engineer Resume
- Lead and sponsor process improvement initiatives
- Responsible for the tools and methods required to achieve process excellence the Solar line of business and across egional locations
- Collate and publish each month the business Balanced Score Card (BSC) with status of indicators, in order to drive improvement where necessary
- Be recognized as an Subject Expert Matter on BMS (ISO9000, ISO 14000, OSHAS etc.) and Continuous improvement methodologies and tools
- Be the main local contact for any update or deployment by Corporate Quality related to Global methods and tools
- Ensure all business processes are aligned to achieve customer satisfaction improvement and desired business results
- Develop strategy and identify opportunities for continuous improvement
- Lead cross-functional team members to utilize various continuous improvement tools and methodologies like Six Sigma, Kaizen etc, to drive business success
4
Responsibilities For Geoint Product Quality System Engineer Resume
- Identify and documents best practices to ensure continuous process improvements
- Leverage best practices across LOBs and within Schneider Electric
- Mentor and assists in development efforts of members of continuous improvement teams
- Organize team to make and fulfill the quality system documentation, coordinate to setup the company quality system, and responsible to supervising and evaluate the implementation status, to make sure the quality system run in efficient way
- Responsible for the external audit, including customer audit (QSB, Q1MSA, Formel Q, etc) and the third party audit (IATF16949, ISO9000, 3C, ISO14001, etc), and responsible the organization, coordination the audit and supervising the auditor NC items improvement and fulfill status
5
Responsibilities For Quality System Engineer Steel Piston Resume
- Responsible for internal audit, to organize team, coordinate and implement the audit, and supervising the improvement actions fulfill status
- Responsible for the training of internal quality system
- Responsible for quality data collection and make monthly quality performance report, and regularly report the quality performance to the superior company
- Others task assigned by department manager
- MMPWT Quality system management and improvement
- Work with HQ to standardize M1 and M2 process procedure, Identify possible quality system improvement
6
Responsibilities For Vmware Quality System Engineer Resume
- Organize internal system audit for the site of MMSH, MMWH, MMCC
- Internal process and new project launch audit
- Organize company certificate yearly audit
- Other works assigned by Quality Manager
- Capacity to apply SPC,MSA
- High knowledge of ISO/TS16949, APQP, PPAP, VDA6.3, M2
7
Responsibilities For Quality System Engineer, Shanghai Resume
- Implementation of internal requirements and external laws, regulations, guidance’s and standards as applicable to Boston Scientific quality systems
- Participate cross functionally and across business units to standardize Boston Scientific Quality System policies and procedures
- Manages the site corrective and preventive actions and product containment process
- Highly motivated individual with the ability to lead cross-functional teams
- Comply with all Corporate / Regional / Departmental Safety, Health, Environmental, and Quality rules / policies / procedures while performing this job whether or not on 3M Property
- Develop and improve the overall Quality Management System for Asia / SEA region
- Spearhead the new / conversion / expansion of QMS certification program for Asia / SEA region
- Liaise with Regulatory or Certification Bodies on audit / surveillance matters
- Support internal or external audits / visits on Quality Management System
8
Responsibilities For Quality System Engineer Resume
- Lead and support Asia/ SEA region on implementation of Corporate and Regional’s QMS initiatives
- Responsible for the QMS harmonization / alignment across Asia / SEA region
- Provide consultant and support related to QMS or audit queries / issues
- Professional Certification: Certified Internal Auditor or Lead Auditor for ISO9001, ISO13485, IATF16949 or equivalent
- Well organized and capable of self-management of projects
- Proactive and assertive attitude
- Travel requirement: 20%-30% per year to ASIA / SEA region
- Runs, manage, coordinate and maintain the management system – including the processes that govern operations and functions – with the aim of meeting the expectations of the stakeholders (Customers, shareholders, partners), as well as the legal and regulatory obligations applicable to both the local aspect and the interfaces with shared services
9
Responsibilities For Senior Quality System Engineer Resume
- Be familiar with product manufacturing process
- Manage and maintain the entity Chorus 2.0 as CCM (Chorus Country Manager)
- Defines the process application assessment plan. Carries out internal audits, assessments (TIMS) and certification procedures (Eg.: ISO9001)
- Makes sure that the management system is performing correctly (process management by Key Performance Indicators [KPIs]) and prepares Management Reviews with data from assessments, audits, customer feedback and complaints. Maintains the monthly KPI dashboard coordinating with all the stakeholders
- Ensures the availability of and standards, and supports their application, as required
- Monitors and works towards customer satisfaction (Eg.: runs and support the entity customer satisfaction survey done by the group)
- University education, mechanical or technical
10
Responsibilities For Senior, Quality System Engineer Resume
- Apply quality control theories and principles to an operational environment.
- Other Technical/Professional Qualification: CQE
- Be familiar with VDA6.3/VDA6.5/ISO14001
- ASQ CQE or CQA certification
- Maintains, enforces, and manages a compliant and effective QMS for the activities in scope, as well as for effective and lean QMS structures and documents for Q&R processes
- Manages the transition/ deployment of the PQMS and manage its deployment
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