Design Quality Engineer Resume Sample
Zaria Oberbrunner
9168 Collier Ridges,
Houston,
TX
+1 (555) 604 2257
Work Experience
Principal Design Quality Engineer
12/2015
-
PRESENT
Philadelphia, PA
- Experience with software quality assurance
- Experience in the medical device industry
- Partner with QA and CMC teams to provide technical quality support to root cause investigations, change control impact assessments, and risk management activities throughout product lifecycle
- Ensure compliance to 21 CFR Parts 4 and 820, ISO 13485, ISO 14971, and other relevant international standards
- Evaluate verification and validation protocols and reports to ensure compliance to external standards and internal standards and procedures
- Provide expertise is risk management and analysis techniques when facilitating completion of FMEAs within a cross-functional team
- Evaluate risk during review of product complaints
Design Quality Engineer
10/2009
-
11/2015
Dallas, TX
- Ensure that required standards for products are documented in the product requirements (PR) specification and ensure compliance by performing quarterly gap analysis and reviewing applicable verification documentation
- Ensure the use of statistically valid sampling techniques
- Author the Quality, Risk and Usability sections of Design Control Quality Plans (DCQP)
- Represent Quality initiatives and compliance when participating and Design and Phase reviews
- Remediate legacy products and documentation as required
- Knowledge of Quality Assurance methods, such as process validation, design of experiments, statistical process control (SPC) and protocol/report preparation
- Knowledge of ISO 13485 and FDA requirements
- Strong computer skills, including MS Office applications (Word/Excel) and statistical software are required
Principal Design Quality Engineer
08/2003
-
05/2009
Los Angeles, CA
- Actively represent Quality function on product/process development teams
- Manage supplier new tooling to ensure final components are qualified at the supplier and on time
- Lead or Participate in the investigation of complex product problems. Identify and manage corrective actions resulting from problem investigations
- Participate in design reviews to evaluate designs and to help identify alternative design solutions
- Identifies and manages risk throughout the development process with the use of FMEAs and/or other risk management tools
- Participate in the development of the master test plans (I.E. trace matrix, VMP….) that encompass design verification, design validation and process validation activities
- Creation, evaluation, and validation of product and process test methods
Education
University of Idaho - Boise Center
1999 - 2003
Engineer's Degree in Engineering
Professional Skills
- Computer Skills: MS Office applications, prior experience with document management platforms (preferably Agile), miniTab experience is an advantage
- Planning skills to prioritize and execute multiple projects
- Excellent problem solving and decision making skills is required
- Excellent problem-solving and decision-making skills is required
- Demonstrated skills in decision making preferably across a broad spectrum of Quality Engineering responsibilities
- Strong collaboration, negotiating, and conflict resolution skills
- Strong electronics troubleshooting skills
How to write Design Quality Engineer Resume
Design Quality Engineer role is responsible for engineering, technical, analysis, conflict, development, english, interpersonal, software, design, applications.
To write great resume for design quality engineer job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Design Quality Engineer Resume
The section contact information is important in your design quality 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 Design Quality Engineer Resume
The section work experience is an essential part of your design quality 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 design quality 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 design quality engineer position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Design Quality Engineer resume experience can include:
- Outstanding communication skills both in Chinese and English with capability to effectively communicate across different areas of functional expertise
- Strong computer skills, including MS Office applications (Word/Excel)
- Have excellent communication and documentation skills and practices
- Superior time management, ability to work on several projects simultaneously and excellent communication skills required
- Self-supporting problem solving skills
- Works cooperatively and effectively within a team environment to achieve common goals and results, often influencing the outcome of the team(s)
Education on a Design Quality Engineer Resume
Make sure to make education a priority on your design quality engineer resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your design quality 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 Design Quality Engineer Resume
When listing skills on your design quality 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 design quality engineer skills:
- Strong engineering skills with a proven track record in process validation and failure mode effects and analysis is also required
- Experiences in quality control and validation planning and/or 3 years experiences on the leader of qualification/quality position
- Excellent verbal and written communication skills including report development and technical presentations
- Good communication skills, to be flexible and motivated and to have a high level of commitment to the success of the project
- Strong teamwork skills mandatory
- Excellent Team Leader Skills
List of Typical Experience For a Design Quality Engineer Resume
1
Experience For Principal Design Quality Engineer Resume
- Demonstrate understanding of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards
- Experience within the Medical Device Industry or an equivalent combination of education, training or experience
- Prior project management experience would be helpful
- Language skills: English native/advanced level
- Develop master test plans that encompass design verification, design validation, and process validation activities
2
Experience For Principal Software Design Quality Engineer Resume
- Lead test method validation for design verification and validation
- Demonstrate mastery and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards
- Excellent root cause analysis and corrective action understanding, including use of lean tools such as 8D, and DFMEA / PFMEA
- Desired - Extensive experience in new product development focused on software / quality engineering related activities in a regulated environment
- Train employees on QMS requirements, and assesses the effectiveness of training
- Sound engineering experience and associated Quality & Inspection knowledge
3
Experience For Senior Software Design Quality Engineer Resume
- Relevant experience in a Quality role
- Knowledge of the Design Controls, and ISO quality requirements is required (FDA/ QSR experience an asset)
- Related experience as a quality, reliability, design or systems engineer
- Own Product and Process Quality System procedures. Ensuring compliance with industry standards and effectiveness in business operations
- Contribute to root cause investigations using various problem-solving techniques and tools, and assesses effectiveness of corrective actions
- Contribute to and support the development of, test methods in equipment, process, and product qualifications/validations
- Write, review, approve design verifications/ validations in accordance with industry expectations
- Support Quality System software validation as needed
- ASQ and/or DFSS certification strongly desired
4
Experience For Principal Design Quality Engineer, Software Resume
- Strong working knowledge of QSR (21 CFR 820) and ISO (13485, 14971) quality requirements
- Previous experience with medical device, productdevelopmentand design/quality controls
- Experience with drug delivery, drug elution, and implants/bioresorbable materials
- Ensure the DHF (Design History File) for new product is adequately maintained and complete each phase prior to product launch
- Understanding of Risk Management, Product Life Cycle, UDI, PDP process, EU market release and packaging
5
Experience For Senior Device Design Quality Engineer Resume
- Understanding of Quality Systems Regulations (QSR 21 CFR Part 820), MDD/MDR, ISO13485 is required
- Provide updates for internal reporting and project tracking needs for business management and external requests on defined timeframes and for special requests
- Anticipate roadblocks, provide direction for navigating the quality system and supporting applications
- ASQ certification in Quality Engineering areas desirable
- Collaborate, review, and approve all project plans, requirements, specifications, tests, test results, traceability, risk management documents, and reports) and maintain a robust Design History File
- Generate documentation at the project level, including software and system risk assessments, and requirements compliance matrices. (ERM)
- Utilize working knowledge of embedded systems and application software
- Develop and maintain compliance policies supporting the ventilation Risk management quality system
6
Experience For Senior Electronics Design Quality Engineer Resume
- Drive QMS & Product continuous improvement through CAPA the process, CAPA investigations, CAPA & compliance audit trending of quality data streams
- Provide expertise and guidance in interpreting governmental risk regulations, agency guidelines and internal policies to assure compliance
- Lead process improvement projects and conduct training with Quality to improve Risk processes the GBUs overall quality system compliance
- Oversee testing and analysis for standards and product requirements compliance
- Interprets, executes, and recommends modifications to operating policies where appropriate
- Occasional lifting of up to 35 pounds
- Follow, interpret and create written Standard Operating Procedures (SOP’s)
7
Experience For Associate Design Quality Engineer Resume
- Monitor the project related Engineering Quality performance indicators and report to the management
- Apply quality methods, within the Engineering Design Process (e.g. FMEA)
- Participate in change review meetings for existing products and new products under development
- Generate metrics for assessing quality and evaluate results
- Assist CAPA investigators by providing guidance to drive to root cause analysis and practical corrective and preventive solutions
- Be customer focused, drive operational excellence, build trusting relationships, and work with a sense of urgency
- Work in a design team setting
- Excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility
8
Experience For New Product Design Quality Engineer Resume
- Ensure that risk analysis documents are continually updated and kept current based on feedback from manufacturing, distribution and clinical use
- Interface with corporate partners regarding design quality issues, audits, and special projects
- Blueprint literacy including GD&T
- Represent the Quality Department for new design and design change efforts, from verification through product implementation in manufacturing
- Working in a regulated industry
- Investigational and Report Writing
- Knowledge of Quality Engineering/Scientific methods and techniques is highly desired
- Broad theoretical understanding and practical knowledge of Quality Assurance process and techniques in Product Development
- Know-how in quality engineering theory and practices, know-how in statistical processes and reliability
9
Experience For Principal Hardware Design Quality Engineer Resume
- Introductory knowledge of Quality Engineering/Scientific methods and techniques
- Mechanical and electronic ability and aptitude to assist with equipment trouble-shooting
- Lead design and development planning activities for new projects
- Familiarity/competency in following areas with in-depth knowledge of at least 3: HPLC, GC, GC/LC-MS, FTIR, UV/Vis, SEM, CE, Chiral Separations, dissolution
- Ensure that project teams comply with all applicable regulations, standards, best practices, and Medtronic procedures
- Participate in technical design reviews (software), project phase reviews, Change Control Board reviews, and Post Market Vigilance trend reviews
- Utilize knowledge of various Software Development Lifecycles (SDLC)
10
Experience For Senior Reliability Design Quality Engineer Resume
- Utilize knowledge of Design Controls, Risk Management, and CAPA
- Participate on cross-functional teams to review marketing requirements and to develop concise, unambiguous, non-conflicting and feasible product requirements that support market needs
- Lead and/or participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, SWFMEA, and risk management report
- Assist with the creation of verification and validation test plans. Oversee testing and analysis for standards and product requirements compliance
- Experience with software quality assurance
- Strong familiarity with regulatory requirements ISO-13485,21CFR 820, ISO-14971, and IEC- 62304
- Assist with the creation of verification and validation test plans
- Provide guidance and direction regarding sample size and statistical analysis
List of Typical Skills For a Design Quality Engineer Resume
1
Skills For Principal Design Quality Engineer Resume
- Have strong communication skills with design and technical actors on verbal, written or visual exchanges,
- Excellent written and communication skills are essential due to the nature of the work
- Utilize coaching and facilitating skills with program shareholders to ensure proper project management, expectation setting, and best practices are utilized
- + Adheres to the competencies and skills for the specified position as defined in the Quality Professional Leveling Matrix
- Experience within the Medical Device Industry or an equivalent combination of education, training or experience
- Years of Experience Required - 3-5 years in electronics manufacturing, design, or testing
- Experience managing tasks or small projects and demonstrating project leadership abilities
2
Skills For Principal Software Design Quality Engineer Resume
- Experience managing tasks or projects and demonstrating project leadership abilities is required
- Demonstrated desire to continually learn and keep up with changing technology
- Contribute to Industrial Design process during RFQ (Request For Quotation), development and PIPAP (Validation and acceptance) phasis
- Strong problem solving with structured methodology such as 8D
- BSc Mechanical engineering or related discipline with 3 years’ experience in a similar role
- 2+ experience in engineering
- Strong working knowledge of QSR (21 CFR 820) and ISO (13485, 14971) quality requirements is required
- Previous experience with Medical Device Packaging solutions
3
Skills For Senior Software Design Quality Engineer Resume
- Conduct/Lead Test Method Validation and Product Verification Testing
- Provides input and direction to other members of the quality assurance department to assist them in their assignments and provide them with learning experience
- Experience in Quality Assurance or Quality Engineering in the medical device industry
- Experience in Engineering, Project management or equivalent
- Experience in product development or engineering in the medical device industry
4
Skills For Principal Design Quality Engineer, Software Resume
- Experience in footwear, manufacturing, plastics or automotive companies
- Experience with Mechanical, Electrical, RF, and Acoustic design integration and testing
- Experience working on an international team
- Demonstrate competence in Quality Engineering body of knowledge
- Proven ability to directly lead and/or co-lead multiple tasks and projects
- Strong familiarity with regulatory requirements (e.g. ISO 13485,CFR 820 EN ISO 14971)
- Experience in risk evaluation techniques, e.g. HHE/HHA, Product Risk Assessment, SFMEA/HHA, DFMEA, FMEA fault tree analysis
- Working knowledge reading or writing software, such as Java code
5
Skills For Senior Device Design Quality Engineer Resume
- Working knowledge of problem solving and statistical methods as applied to process and product quality
- Understanding of measuring techniques (for example, mechanical, optical, gages, automation)
- Working knowledge of bringing software products or apps from ideation to market
- Understanding of measuring techniques (for example, mechanical, optical, gages,
- Sitting approximately 50% of day and standing approximately 50% of day
- Working knowledge of FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971, WEEE, RoHS, and IEC 60601 standards
- Willing to travel 10 - 20 % globally
- Working knowledge of risk management and design controls (generation of system risk analysis, DFMEA, PFMEA)
- Working knowledge of Quality Engineering and medical device regulations (FDA 21CFR 820, 806, 803, 804, ISO13485, and MDD)
6
Skills For Senior Electronics Design Quality Engineer Resume
- Support the detection of quality issues by challenging and verifying the quality of critical engineering deliverables
- Get to work with the best teams in the industry, ranging from top-level scientists to cutting edge process- and production teams
- Technical understanding of manufacturing equipment and processes
- Contribute to process improvement efforts by developing and/or updating written company or departmental procedures
- Electronic or Electro-Mechanical design office background that could include some of PCBs, PCB assemblies, Black box design, looming or cabling
- Airframe structures (mechanical) design office background that could include fabrication, machining, mechanical assemblies and Geometric tolerancing
- Conduct design assessments regarding product quality during entire Product Development process: Product Concept to Initial Mass Production
- Develop test plans and equipment for component and product evaluations, including packaging qualification
- Interact and form constructive working relationships with all levels of leadership within Quality, Procurement, Marketing, R&D, and Operations
7
Skills For Associate Design Quality Engineer Resume
- Deep understanding of Risk Management, Product Life Cycle, UDI, PDP process, EU market release and packaging
- Familiar with injection molding and molding defects
- Plan and coordinate biocompatibility, sterilization, aging and packaging/distribution studies
- Document communication from customers regarding complaints, including clinical AEs for commercial products
- Support external audits (e.g. scribing, screening documents)
- Problem solving orientation to diagnose root causes and recommend solutions in assigned area
8
Skills For New Product Design Quality Engineer Resume
- QMS implementation and lead auditing to recognised aerospace standards
- Self-starter with a desire for problem solving and process improvement
- Responsible for ensuring compliance of design quality processes such as Root Cause Analysis, QMSLive, Management Signoff Dashboard, Hoshin, dPDM & CMMi
- Responsible for re-engineering the design processes and ensure processes evolve to achieve the design quality goals
- Assure Engineering and Program Management compliance with Teledyne Controls, Contract, AS9100, ISO9001, and FAA standards and established processes
9
Skills For Principal Hardware Design Quality Engineer Resume
- Apply working knowledge of Design and Development of Software to DO-178, AS9115 and of Hardware to DO-254
- + Utilize working knowledge of embedded systems and application software
- + Provide guidance and direction regarding sample size and statistical analysis
- Familiar with Design for Manufacturing / Design for Assembly / Design for Test
- A career in an international company and to be part of exciting projects to improve human conditions
- Thorough understanding of medical device quality system regulations
- Introductory knowledge of Quality Engineering/Scientific methods and techniques is highly desired
- Blueprint literacy including GD&T is required
10
Skills For Senior Reliability Design Quality Engineer Resume
- Use of Electrical Testing Equipment
- Collaborate closely with I&D PMO and project leads to bring products to market
- Prepare DRAM Engineering Group sites for internal and external audits
- Coordinate with DRAM Engineering Groups to prepare for audits
- Support design control activities for product improvement efforts for existing products
- Knowledge of DRAM manufacturing, test and qualification process
- Knowledge of the know-how in quality engineering theory and practices, know-how in statistical processes and reliability
List of Typical Responsibilities For a Design Quality Engineer Resume
1
Responsibilities For Principal Design Quality Engineer Resume
- Supports all global training programs specific to their customer by development and implementation of specialized training sessions for all applicable functions
- Experience in product design and development related work experience with exposure to regulated products
- Interpersonal skills that foster conflict resolution as it relates to technical situations is required
- Proved experience with risk management processes
- Demonstrated scientific analysis abilities
- Experience with New product introductions at global contract manufactures
2
Responsibilities For Principal Software Design Quality Engineer Resume
- Responsible for effective transfer of product from research and development ot manufacturing
- Develop and execute validation plans, methods and protocols
- Support multiple projects, balancing priorities and resources to meet project and management expectations
- Strong familiarity with regulatory requirements ISO 13485,CFR 820 EN ISO 14971, IEC 62304
- + Assist with the creation of verification and validation test plans
3
Responsibilities For Senior Software Design Quality Engineer Resume
- Fully engages with the involvement of Hardware and Software design and development review meetings (requirements, design, and validation/verification)
- Support FDA 21CFR820/EU MDD/MDR, ISO13485 requirements by creating and reviewing design control deliverables and requirements
- Comparative Statistical techniques, sampling plans, GRR, K-factor, hypothesis testing and ANOVA
- Provides support for all quoting activities by participation in initial process design, development, and implementation phases
- Drive product and process non-conformance investigations and associated root cause analysis activities including concession management
4
Responsibilities For Principal Design Quality Engineer, Software Resume
- Support the identification and mitigation of engineering related quality risks
- Provide Design Quality Engineering support to cross-functional development teams for NP Medical Inc. products
- Prepares Quality Assurance Plans; Performs product test witness/monitoring in laboratory environment
- Provides support Statistical and Status Reporting and DQA Metrics
- Performs hands-on Software SOI (Stages of Involvement) audits; Assist in new staff orientation and training
- SUPPORT NEW PRODUCT DEVELOPMENT & PRODUCT CHANGE MANAGEMENT BY
5
Responsibilities For Senior Device Design Quality Engineer Resume
- To work as an integral part of a QARA team for Thermo Fisher’s Microbiology Division business
- Assume a Subject Matter Expert (SME) on Product Software development process activities and related workflows in relation to regulatory compliance, provide ‘solution-based’ problem resolution
- Exceptional interpersonal and communication skills. Excellent attention to detail. Ability to work on one’s own initiative. Demonstrate sound judgment/rationale. Excellent report writing and reviewing skills
- Manage and host Product Development auditing activities
- Ensure implementation of robust change control and configuration management process
6
Responsibilities For Senior Electronics Design Quality Engineer Resume
- Manage Quality escapes and Customer investigations
- Conduct required First Article Inspections and ensure smooth transition of new products into production
- Support the project engineering by scoping and proposing the usage of quality related methods and tools (such as FMEAs, Design Reviews, Problem Solving, Feedback, Process Audits etc.)
- Train and support the engineering teams to use the agreed methods and tools
- 10%: Partner with QA and CMC teams to provide technical quality support to root cause investigations, change control impact assessments, and risk management activities throughout product lifecycle
- 5%: Ensure compliance to 21 CFR Parts 4 and 820, ISO 13485, ISO 14971, and other relevant international standards
7
Responsibilities For Associate Design Quality Engineer Resume
- Manage and update DRAM Component (silicon) DFMEA
- Review technical content of DFMEA items
- Maintain DRAM DFMEA methodology
- Attend DFMEA Meetings as DRAM Design representative
- Provide and coordinate input to the DFMEA to PFMEA projects
- Partner with external design/development and/or manufacturing partners on development activities, including risk management, quality planning, and design transfer
- Partner with QA and CMC teams to provide technical quality support to root cause investigations, change control impact assessments, and risk management activities throughout product lifecycle
- Applies appropriate statistical methods and tools to various product development and manufacturing activities
8
Responsibilities For New Product Design Quality Engineer Resume
- Ensure compliance to 21 CFR Parts 4 and 820, ISO 13485, ISO 14971, and other relevant international standards
- Support design control activities for new product development efforts from design concept through product launch activities
- Other areas of responsibilities/support are Supplier Quality, Product Issue Assessments, Health Risk Evaluation, and Post Market Surveillance
- The ability to use Quality Engineering principles, tools, and practices to develop and optimize systems and processes that are aligned with the overall business and quality vision is required
- Represent Quality Assurance and Regualtory Affairs on cross-functional Product Development core teams
- Identify and drive process improvement activities related to product development
- Develop, trend, monitor, and report on quality performance metrics
- Supports quality system audits as needed
- Competency in the FDA Medical Device Quality System Regulations and ISO 13485
9
Responsibilities For Principal Hardware Design Quality Engineer Resume
- Support new product development and design through design verification activity
- Develop risk assessment, inspection methodology and acceptance criteria for inspection sample plans and conduct audits of new suppliers as part of the project teams
- Know and follow all laws and policies that apply to the job, and to maintain the highest levels of professionalism, ethics and compliance at all times
- Participate as a core team member on Product Development Teams representing all Quality functions: Test, Manufacturing, Supplier Quality and Consumer Technical Assistance
- Ensure product meets Regulatory and Compliance requirements
10
Responsibilities For Senior Reliability Design Quality Engineer Resume
- Perform root cause analysis and recommend corrective action
- Communicate product status to core team and management
- Travel as required for project related support
- Support the development and manufacturing of medical devices in conformance with the Quality System Regulation, ISO 13485, Medical Device Directive, ISO 14971, IEC 60601, ISO 62304, ISO 62366, and other regulatory standards
- Lead all risk management activities, ensure procedures and files are maintened to State of the Art, and ensure all applicable staff are sufficiently knowledgable
- Contribute to the streamlining and continuous improvement of the product development process to ensure robust and efficient development and launch of new and innovative healthcare products
- Provide guidance and interpretation for industry related regulations within the framework of Cardinal product and sustaining development processes
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