Quality Systems Engineer Resume Sample
Mitchel Ryan
24941 Sandrine Lodge,
Chicago,
IL
+1 (555) 164 1964
Work Experience
Quality Systems Engineer, Senior
06/2016
-
PRESENT
Boston, MA
- Strong Communication skills – verbal, written, presentation to an audience of 1 to 100 or more
- Experience with structured improvement processes such as Six Sigma, QFD, LEAN, TQM, etc
- Strategy formulation - ability to analyze the requirements, identify the gaps, develop and execute actionable plans to close those gaps
- Facilitation - ability to work with several organizations with differing needs and develop an agreed upon solution to meeting the requirements of standards
- Partnership/Teamwork - ability to work well with a variety of people and be flexible to take on different roles/responsibilities as projects change
- Influencing skills - strong business partnership, business process analysis, and influencing skills. Heavy interaction at the decision-making manager/director/VP level
- Analysis skills – metric creation, trend analysis and identification
Quality Systems Engineer
03/2010
-
02/2016
San Francisco, CA
- Knowledge of Functional Business processes, models and life-cycles
- Keep the reports updated of 3 Up’s, Warranties, QMs, Weekly Warranty Report, Security Report, daily report, etc
- Ensures compliance of the Corrective Action and Preventative Action system
- Leads quality projects with cross functional teams
- Maintains quality records on product testing, nonconformance, project outcomes, and stakeholder input filed in an accurate and timely manner
- Coordinates change control documentation and approval process
- Makes proposals and assists in the development of corrective and preventative action plans and monitors implementation
- Follows up on closure of corrective and preventive actions
Advance Quality Systems Engineer
10/2007
-
10/2009
New York, NY
- Provides quality support for technology transfer and improvement of existing manufacturing processes
- Develops and conducts Effectiveness Monotoring actions
- Conducts investigations, collects data, analyzes trends and prepares reports for assigned quality processes. Has thorough understanding of process criteria and regulations and business impact of decisions and actions
- Assesses current quality systems and recommends improvements in order to enhance quality and reduce cycle time
- Prepares for and facilitates audits and inspections
- Assists in the development, implementation and review of standard operating procedures
- Maintain current knowledge of the FDA regulations (frequent reading of the trade press/emails, FDA news bulletins, attending job-related webinars, or outside courses when appropriate); consider innovative solutions to meet changing regulatory compliance goals
- Maintain current knowledge of ISO 13485
- Performs the investigation of Out of Tolerance Conditions (OOT’s) with calibration
Education
Clark University
2001 - 2006
Engineer's Degree in Engineering
Professional Skills
- Strong interpersonal and communication skills; strong collaboration and customer service skills
- Strong organizational, practical mathematical (statistical) skills, analytical and problem solving skills
- Strong analytical and problem solving skills, and demonstrated capacity for accuracy
- Demonstrates excellent customer service skills with the flexibility to respond to changes quickly
- Excellent interpersonal and communication skills at all levels (including speaking in front of groups and chairing internal / external meetings)
- Proven cross-functional collaboration, teamwork, and solid decision-making skills
- Excellent interpersonal, negotiation, communication, writing and computer skills
How to write Quality Systems Engineer Resume
Quality Systems Engineer role is responsible for analytical, excel, computer, interpersonal, analysis, auditing, microsoft, organization, leadership, manufacturing.
To write great resume for quality systems engineer job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Quality Systems Engineer Resume
The section contact information is important in your quality systems 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 Systems Engineer Resume
The section work experience is an essential part of your quality systems 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 systems 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 systems engineer position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Quality Systems Engineer resume experience can include:
- Strong computer knowledge (MS Office), technical writing skills and proofreading ability
- Good working skills with Microsoft Office software
- Excellent verbal and written communication skills with the ability to present information concisely with supporting data
- Strong Excel skills to include design, calculations, macros and analysis
- Demonstrated ability writing and approving documents, which help explain technologies, processes and products including validations
- Experience in tracking, analyzing and interpreting quality data and use these data to identify effective process improvements
Education on a Quality Systems Engineer Resume
Make sure to make education a priority on your quality systems 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 systems 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 Systems Engineer Resume
When listing skills on your quality systems 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 systems engineer skills:
- Build constructive and effective relationships inside and outside the organization and demonstrate strong conflict resolution skills
- Excellent interpersonal skills and very good computer literacy
- Demonstrate clear and effective communication skills with stakeholders and management
- Demonstrated technical and professional skills in job-related area required, with ability to handle complex scenarios, and prioritize multiple issues
- Possess outstanding written and verbal communication skills with the ability to effectively communicate on technical topics
- Project Management Skills or experience with Project Management is essential
List of Typical Experience For a Quality Systems Engineer Resume
1
Experience For Quality & Systems Engineer Resume
- Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques
- Extensive experience utilizing and/or training quality tools/methodologies including, but not limited to, APQP, PPAP, MSA, SPC
- Experience in Semiconductor Manufacturing related Quality Engineering
- Advanced Microsoft Excel experience, including creating tables, charts, graphs and pivot tables, etc
- Strong understanding of Semiconductor Industry best practices for Quality Management Systems, compliant to ISO 9001 an/ or ISO TS16949 requirements
- Experience in ManufacturingData mining and use of same for Quality Analytics
- Experience in quality related jobs inside manufacturing companies
- Effective communication with both internal and external customers both orally and in writing required
- 7 to 10 yrs experience supporting a medical device/pharmaceutical environment in a process development capacity
2
Experience For Advance Quality Systems Engineer Resume
- Demonstrated knowledge of statistics, problem solving and quality management equipment and systems
- Apply sound systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving vendor quality issues
- Works actively to measure process value streams for effectiveness and implements improvements as required
- Experience as a technical project/program manager, preferably within an enterprise software development environment
- Experience in software project management, deep knowledge of software development processes, challenges, and culture
- Action oriented with a proven ability to influence others
3
Experience For Quality Systems Engineer, Senior Resume
- Facilitate efficient and effective processing of CAPA’s and audit non-conformances
- Demonstrable competence gained through successful experience from similar role, preferably with Medical Devices
- Performs process qualifications and validations programs in support of reducing or eliminating inspection sampling and creating acceptable process controls
- Providing support for Audit and Training Program related issues, including but not limited to the generation and processing of AFs, DCNs and CAPAs
- Reviewing and improving existing process controls for quality metrics / Quality Systems
4
Experience For Iatf Quality Systems Engineer Resume
- Understanding of quality techniques and best practice relating to: CAPA, Vigilance activities, and internal / external auditing
- Assisting in creation of Quality Standards and visual aids for use in Training program
- Understanding of computer software including Word, Excel and Access
- Willing to work under pressure and persistent on making improvement/change
- Understanding Immunodiagnostic product realisation process
- Working knowledge of 21 CFR Part 820 and ISO 13485 is required
- Providing QM support for Post market activities and representation on various product related meetings
- Support manufacturing and quality teams in developing, implementing and maintaining Process FMEAs and Control Plans
- Directs colleagues engaged in measuring and testing product and tabulating data concerning materials, product, or process quality and reliability
5
Experience For X-ray Image Quality Systems Engineer Resume
- Provide training and support for the Quality Technicians and manufacturing colleagues, including gage training
- Develop the capabilities of those in the location through teaching, coaching, establishing high standards, and ensuring accountability
- Lead and perform internal audits. Assist in planning and facilitating internal auditor training
- Design and implement current and future state Quality business process with customer stakeholders, including Manufacturing, Product Engineering, GPS, etc
- Oversee and participate in process events affecting Fulfillment, including LEAN events, to ensure alignment with existing or new processes
6
Experience For V Mware Quality Systems Engineer Resume
- Provide QMS support by working closely with Sales, Engineering, and Manufacturing to manage customer relations, expectations, needs and satisfaction
- Capable of reviewing and interpreting drawings, contracts / PO’s, and applicable processing standards
- Responsible for driving continuous improvement activities by maintaining the following key elements of the Global Operations Quality Management Systems
- Establish/maintain key performance indicators and systems for tracking, reporting and improving performance
- Ensure all mandatory training requirements are set and training is executed as required
- Facilitate external and customer audits, and drive any audit finding to closure with actions required by utilizing Conducting Root Cause Analysis (RCA) and Corrective Action (CAR) efforts
- Identifies gap on quality system knowledge of learning and development , therefore source internal and external expertise to carry out training
- Participate with and support plant Teams, raising issues of concern, working with the teams to resolve and improve performance
- Knowledge of auditing and maintaining AS9100 / IATF 16949 quality standards
7
Experience For Quality Systems Engineer Capa Resume
- Initiate, facilitate and participate in cross-functional teams in pursuit of problem solving and mistake proofing quality problems
- Participate in and drive Quality Improvements projects, including updating workflows and specs
- Knowledge of AutoCAD, and proficient in the drafting and editing of electronic based drawings
- Food Engineering, thermal heat processing and fluid flow are advantageous
- Basic understanding of Corrective and Preventive Action, Nonconforming Product regulations
- Comfortable speaking with and presenting to site leadership
8
Experience For Advanced Quality Systems Engineer Resume
- Knowledge and understanding of core engineering tools (i.e.: PPAP, APQP, FMEA, and Q1)
- Perform review of customer quality requirements during proposal and contract review
- Champion and promote passion in advancing Lean, continuous improvement, and customer delight
- Assesses quality system need and deploy training and lessons learned for both salaried and DL/IDL employees
- Supervises lab operation, DCC, calibration and maintenance system running well
9
Experience For Body Quality Systems Engineer Resume
- Initiate/participate in corrective action and problem solving activities
- Participates in UAT testing protocols with key users
- Delivers systems level training to all user groups through Work Instructions, Web Collaboration, and Face to Face workshops
- Supports global process understanding and implementation
- Assist Tech Service and Complaint Coordinator with customer complaint investigation, testing, and resolution
- Broad exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines (Electrical, IQ, Systems, Software, etc.)
- Manage Site Quality Management Systems including CAPA, Internal Audit, Change Management and Management Review
- Be a primary contact for other departments providing quality guidance to assure compliance
10
Experience For Engine Systems Quality Systems Engineer Resume
- Manage the Corrective Action projects to ensure they are getting closed in a timely manner
- Has expertise in internal auditing techniques and is familiar with all regulatory requirements (e.g., FDA, ISO and MDD/MDR )
- Familiar with the internal auditing system
- Maintenance of the Process Sign Off Books, and job books (for manufacturing)
- Responsible for reporting all accidents, however minor, and all workplace hazards to the supervisor immediately
List of Typical Skills For a Quality Systems Engineer Resume
1
Skills For Quality & Systems Engineer Resume
- Self-starter, high energy person with excellent verbal and written communications skills
- Good computer skills relative to Excel and Word
- Good written and oral communication skills: able to communicate complex information to all levels of the organization, and able to prepare data to be presented
- Network oriented and able to interact with different business functions and can work within numerous systems, strong organizational skills
- Strong written and verbal communication, interpersonal and presentation skills to lead personnel to drive results
- Extensive experience of Quality in a manufacturing environment and experience during all lifecycle phases would be advantageous
- Computer skills — proficient using business software packages, including MS Office
- Have analytical problem solving skills
- Prior experience in a regulated manufacturing environment (medical, pharma or food)
2
Skills For Advance Quality Systems Engineer Resume
- Develop good documentation best practices; develop a training plan; monitor effectiveness; coach others as needed
- Auditor skills, e.g. attention to detail, organized thinker, personable communicator with all levels, ability to connect threads of information together
- It is an advantage to have knowledge on Validation and CAPA Policies or FDA regulations in relation to validation
- Communicate effectively with customers and key stakeholders at all levels within the organisation
- Six Sigma or Lean skills and tools exposure advantageous
- Effectively communicate and team with a wide variety of individuals from technicians to executive level staff
- Effectively support multiple deliverables at once
3
Skills For Quality Systems Engineer, Senior Resume
- Prior experience with eCAPA system
- Advanced Microsoft Office skills (excel, word)
- High level of analytical ability, leadership, and verbal/written communication skills
- Appropriate interpersonal styles and communication methods to work effectively with key business partners
- Prior experience with ERP systems such as AX or SAP
- Analytical, mathematical, and problem solving skills
- Leadership skills including ability to maintain confidentiality
4
Skills For Iatf Quality Systems Engineer Resume
- Good generalist (experienced quality person)
- Engineering, change control, and project management experience
- Broad quality engineering experience, including working with suppliers, internal factory personnel, and customers
- Cross functional experience working in a range of areas e.g. Supply Chain, Manufacturing, Engineering
- Experience in a similar role maintaining/updating quality systems
- Demonstrated ability to teach methods of analysis and written reporting to trained but not engineering staff
- Progressive experience working in a Quality Engineering capacity within aerospace or automotive environments
5
Skills For X-ray Image Quality Systems Engineer Resume
- Combined Manufacturing Engineering and Quality Systems experience with a focus on Design Control and CAPA
- Experience in developing or improving quality management systems
- Proven ability of working in a cross-functional team environment and also working on own initiative
- Previous experience of working in a regulated industry in a scientific / technical environment would be advantageous
- ISO 9001 Lead Auditor / integrated auditing experience
- Maintains a strict control over corrective and preventive actions from internal and external sources, while assuring its effectiveness
- Implements change control systems assuring safe and effective implementation
6
Skills For V Mware Quality Systems Engineer Resume
- Broad experience of applying the Quality Tools & Techniques - PFMEA, 8D, Control Plans, Measurement System Analysis
- Experience in a customer or supplier facing role
- Experience in Quality Auditing and notified body inspections is required
- Experience in business process improvement using Lean/Six Sigma
- Experience in quality related role within manufacturing environment
- Experienced in leading quality initiatives
- Experience auditing Quality Management Systems or elements thereof
- Experience implementing process improvement methodologies (e.g., Six Sigma, Lean)
- Strong MS Access development using VBA
7
Skills For Quality Systems Engineer Capa Resume
- Strong MS Excel development using VBA
- Experience working within a quality system
- Quality related experience in a manufacturing environment
- Experience working with ISO 9001:2008 and 2015 standards and compliance activities
- Experience performing QMS related work
- Experience supporting Customer QMS audits
8
Skills For Advanced Quality Systems Engineer Resume
- Strong working knowledge of AS9100/9102/9120 quality standards
- Experience working in an ISO certified environment required
- Experience in automotive Quality Engineering
- Experience with Tier One Automotive manufacturing
- Experience with Geometric Dimensioning & Tolerances (GD&T)
- Experience supporting a medical device/pharmaceutical environment in a process development capacity
9
Skills For Body Quality Systems Engineer Resume
- Effective communication between Production Employees, Operations, Engineering and Quality
- Experienced in technical writing and review
- Proven ability of working within an established Quality System
- Experience with formal problem solving tools such as 8D
- Skilled at performing First Article Inspections
- Experience with development/delivery of training programs and/or complaint investigations
- Solid working knowledge of PPAP processes
10
Skills For Engine Systems Quality Systems Engineer Resume
- Researches, formulates, and documents quality, environment and business systems improvements as well as evaluating effectiveness of improvement efforts
- Gathers audit findings and analyze key detractors then form up effective corrective action/preventive actions, by collaborating with cross functional team
- Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC, trend analysis, etc
- Responsible for compliance to West Pharmaceutical Systems Division, Contract Manufacturing validation program
- Plastics manufacturing experience
- Previous experience in a similar Industry is desirable
List of Typical Responsibilities For a Quality Systems Engineer Resume
1
Responsibilities For Quality & Systems Engineer Resume
- Collaborates across function, leveraging others’ quality and manufacturing expertise to troubleshoot problems, interpret data, find root cause, determine next steps, and create technical reports
- Effective communication skills and boundary-less behavior—ability to present ideas clearly and concisely
- Skills in planning, organization and schedule compliance
- AS/AA (min) in an Engineering discipline or equivalent training/experience
- Min 1 year of experience in electronics Manufacturing environment or equivalent
- Experience in manufacturing industry
- Good understanding of cGxPs
2
Responsibilities For Advance Quality Systems Engineer Resume
- Experience working within an established Quality System
- Leading or participating in FMEA or RCA/CAPA development teams
- Working knowledge of AS9100 or IATF 16949 Quality Management Systems
- Training in QMS requirements (e.g., FDA QSR 21 CFR 820; ISO 13485)
- Understanding of FAA requirements specific to FAR part 21
- Working knowledge of Six Sigma / Lean principles
- Working knowledge of GMP’s and other FDA regulations and CMDR
- Understanding of Quality Assurance processes is essential
- Resolving issues within the application through use of problem-solving techniques, interaction with internal IT organization and vendor’s support system
3
Responsibilities For Quality Systems Engineer, Senior Resume
- Assisting QA Engineers, Complaint Handlers and QA Manager in the collection, analysis and reporting of data
- Participating in External Audits as required
- Assist in defining/developing Quality Program status indicators, performance measurements and reporting requirements
- Certification (e.g., ASQ) or training in relevant Quality disciplines such as Quality Engineering, Auditing, or Six Sigma
- Perform adequacy reviews for flow down of QA requirements to implementing documents and quality affecting processes
- Provide onsite support at TRW and Customer Plant during launch
4
Responsibilities For Iatf Quality Systems Engineer Resume
- Adoption of the company's interests regarding strategic management of quality and environment
- Six Sigma Black Belt or Green Belt certification or training
- Proficient in the use of digital/analog measuring instruments, e.g., micrometers, calipers, linear and dial gauges, height gauges, and a visual comparator
- An understanding of use and application of SPC
- Knowledge of resistance and MIG welding processes
- Root cause problem solving ability
5
Responsibilities For X-ray Image Quality Systems Engineer Resume
- Support the implementation of paperless manufacturing initiatives
- Knowledge and understanding of ISO 9001 standards required
- Investigates, and resolves system nonconformances (defined during internal and/or external audits)
- Continually work with colleagues and suppliers to ensure that all processes meet on going best practice, ISO compliance and SIL compliance
- IPC 610 Specialist training is required
- Work with Manufacturing on internal quality issues
- Assist in the launch of new products of the improvement of existing products
- Evaluates regulations to translate requirements into user friendly Standard Operating Procedures and Work Instructions
- Actively participate in definitions of test requirements, justification of acceptance limits and sampling plans to assure compliance with requirements
6
Responsibilities For V Mware Quality Systems Engineer Resume
- Application of testing and inspection activities to specific systems
- Assist in developing of quality system processes, i.e., records management and document control, control of electronic data, software development and control
- Develop Quality System training material for Operation and Business units
- Highly familiar with structured problem solving assets, preferably 9Step BPS, SD, RCCA, 5-Whys’
- Basic understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485
- Six Sigma Qualification and high competence in data analysis and LEAN manufacturing. Green Belt qualification desirable
- Yellow Belt Six Sigma Training
7
Responsibilities For Quality Systems Engineer Capa Resume
- Comply with Abbott corporate policy which prohibits the use of products containing tobacco on Abbott property
- Knowledge of Manufacturing Execution systems and applications
- Knowledge of electronics/wiring harness industry
- Specialized courses in engineering, quality, personnel administration or a specialized discipline, and
- Control and follow-up with the engineering changes to ensure the correct implementation of new projects and products are underway
- Investigates, and resolves system nonconformance’s (defined during internal and/or external audits
- In-depth working knowledge of cGMP principles and applications
8
Responsibilities For Advanced Quality Systems Engineer Resume
- High level knowledge of Lean manufacturing methodologies
- Knowledge and understanding of Statistical Process Control techniques
- Understand Davenport Works Quality Management System, including the electronic system and information flow that support this overall system
- Identify and remove the quality barriers to manufacturing and supplier performance excellence
- Actively participate as a member of PROLaunch New Product Development Teams to bring new products to market when required.
- Ensure well being of employees by implementation of pro-active practices and processes e.g. 5S Audits, Safety Walks and risk assessments
9
Responsibilities For Body Quality Systems Engineer Resume
- Conduct internal and customer audits, as well as follow-up on corrective actions arising from audits
- Interpret and provide guidance on applicable and upcoming federal and international regulations
- Problem Solving Techniques (8D´s, 5 Why´s)
- Sound Knowledge & understanding of ISO 9000:2015 principles
- Support FMEA, PFC & CP with interfaces between the customers assembly groups and the suppliers
- The position recognizes that accident and injury prevention are equal in importance to production, quality, delivery, recovery and cost control.The incumbent accepts the responsibility to work safely, practicing and promoting safety consciousness through Arconic EHS standards and practices
- Maintain and evaluate GFPT’s corrective action program
- Evaluate business goals, identify improvement opportunities and apply scientific methods, statistics and problem solving techniques to improve and sustain product quality and process effectiveness
- Support all Quality Assurance activities for internal and external customers
10
Responsibilities For Engine Systems Quality Systems Engineer Resume
- Provide leadership in development of quality documentation such as Design Failure Mode Analysis, Process Failure Mode Analysis, Control Plan, Dual Launch Netting Agreements for both Proto-type & Production
- Provide leadership during corrective action activities. Prepare and present pre-production and design related corrective action reports to TRW Management and customer
- Support the development and administration of the customer corrective and preventative action (CAPA), internal non-conformance and Quality Management Systems
- Support production related corrective actions as required. Track issues to closure and update lessons learned
- Conduct line walk audits at TRW plants. Document audit findings. Generate action item matrix. Conduct post audit review with the appropriate plant personnel. Track issues to closure
- Support the Production Part Approval Process. Specific requirements on Build Plan Worksheet. Support PPAP Coordinator in tracking documents and obtaining customer approval
- Lead the re¬certification / surveillance audit process to maintain company certificates
- Determination, achievement and maintenance of management system in conformity with ISOTS16949 and ISO 14001, Continental AG and customer requirements
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