Senior Design Quality Engineer Resume Samples

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J Goodwin

Jazlyn

Goodwin

45086 Bernier Ranch

Phoenix

+1 (555) 287 4921

45086 Bernier Ranch

Phoenix

Phone

p +1 (555) 287 4921

Experience Experience

Dallas, TX

Senior Design Quality Engineer

Dallas, TX

Schuppe, Paucek and Mitchell

Dallas, TX

Senior Design Quality Engineer

Supports design test and inspection method development and validation
Provide effective quality engineering support for new product transitions into commercial production
Generate, review and approve Engineering and Development Change Orders for Design Assurance
Take initiative to identify and drive improvements to the Illumina quality system
Function as a quality lead on multiple product development teams in matters relating to Quality Engineering
Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues
Identify areas and opportunities to improve quality system processes

Chicago, IL

Senior Design & Quality Engineer

Chicago, IL

Ankunding and Sons

Chicago, IL

Senior Design & Quality Engineer

Working knowledge of network routing, switching and security
8 years working as a Quality Engineer
Expert knowledge of Linux and Microsoft operating systems
Expert level user for Visio and or other similar design tools
B.S. Computer Science
Develops master test plans that encompass design verification, design validation and process validation activities
Lead the investigation of complex product problems. Identify and manage corrective actions resulting from problem investigations

present

Los Angeles, CA

Senior Design Quality Engineer New Product Development

Los Angeles, CA

Buckridge LLC

present

Los Angeles, CA

Senior Design Quality Engineer New Product Development

present

Product development team member focused on product development and life cycle management activities related to the Trauma/CMF business
Support risk management activities including planning, design & clinical risk management, production risk management, and overall risk summary reporting
Provide technical support and methods to assist production
Enhance the design control and risk management processes to better reflect state of the art practices and drive continuous improvement
Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
Supports in the development and maintenance of Quality Management System procedures
Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis

Education Education

Bachelor’s Degree in Engineering

University of California, Santa Barbara

Bachelor’s Degree in Engineering

Skills Skills

Function as a quality lead on multiple product development teams in matters relating to Quality Engineering
Positive attitude & good communication skills
Lead investigation of quality issues and effective corrective and/or preventive action
Self- starter, with the ability to work independently and with all levels of managers, associates, and clients
Communicate at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing
Certified Quality Auditor (CQA)
Certified Quality Engineer (CQE)
Good English Skill and Mandarin skills
Familiar with IEC 60601, ISO 5361, ISO 5366 and product specific industry standards. Desirable
Familiar with DMAIC or DMADV(DFSS) methodologies Desirable

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Senior Design Quality Engineer Resume Examples & Samples

BS and/or MS in engineering or equivalent technical discipline required, and advanced degree preferred
6+ years of device and/or combination product development within a medical device or biotech or pharmaceutical organization required, including minimum of 2 in design quality, required
Extensive knowledge of both US and International Design Control and Risk Management requirements (specifically 21 CFR Part 820, ISO 13485, ISO 14971), as well as other applicable standards required
Experience in leading design quality activities required
Experience with drug delivery injection systems required

Senior Design & Quality Engineer Resume Examples & Samples

8 years working as a Quality Engineer
In depth understanding of Polycom core infrastructure and components
Expert knowledge of Linux and Microsoft operating systems
Understanding of coding and development principals. Development is not necessary but candidate must be able to communicate with developers at a programatic level and write development requirements
Working knowledge of network routing, switching and security
Excellent technical research and writing skills
Expert level user for Visio and or other similar design tools
B.S. Computer Science

Senior Design Quality Engineer Resume Examples & Samples

BS. in Engineering or associated scientific discipline
Minimum of 4 years medical device experience in Quality or R&D Engineering position with design control and product development experience
Strong working knowledge of risk management, CAPA, and Design Controls
Strong working knowledge of Medical Device Regulations, FDA Guidance Documents and Industry Standards
Proficient with Minitab - Comparative Statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing and ANOVA
Reliability and Human Factors engineering experience
ASQ CQE, CQA, CSQE and/or CRE certification (preferred)
DFSS Black Belt (preferred)
Agile (preferred)
Experience working across geographies and working in a cross-functional team environment
Excellent problem solving skills, including demonstrated application of structured problem solving methods and tools
Demonstrated critical thinking skills with focus on improved system performance outcomes and positive business impact
Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience)
Strong collaboration and influence skills (build relationships, leverage others, align and work towards shared outcome-based goals, understand others’ needs, negotiate for win-win, own the whole)
Proficient in Microsoft Word, Excel, Minitab and managing electronic data files

Senior Design Quality Engineer Resume Examples & Samples

Good communication skills, both written and oral and must be computer literate
Knowledge of or experience in developing and manufacturing medical devices in conformance with Quality System Regulations and ISO 13485 requirements
Knowledge of analytical tools and methods, including statistics (Minitab preferred), DOE and the use of computer/software packages related to design, development and manufacturing
Preferred Skills/Qualifications
Minimum (7) seven years’ experience in design, manufacturing or quality engineering position (medical device experience preferred). Three years of experience can be substituted for an Advanced degree in a related discipline. Experience with analytical tools and methods, including statistics (Minitab preferred), DOE, and the use of computer software packages related to design, development and manufacturing. Statistical Quality Control/Statistical Process Control, Design of Experiments, Failure Mode and Effects Analysis. Experience in a regulated environment (FDA, ISO, etc.)

Senior Design Quality Engineer Resume Examples & Samples

B.S. degree in Engineering or associated fields, or equivalent industry experience
Knowledge and expertise in supply chain management and supplier development, stakeholder management, risk/issue management, implementation planning, training/communication, scope management
Broad business knowledge and ability to link customer needs with business
MS Office (Excel, PowerPoint, Outlook)
Certified Quality Engineer (CQE) / Certified Quality Auditor (CQA) preferred
MS Project, Minitab
ASQ certification in Quality Engineering desirable

Senior Design Quality Engineer Resume Examples & Samples

Minimum 5 years experience in Quality Assurance, including Quality systems, standards, metrics, and tools
OpEx experience required: Six Sigma strongly desired
Mastery of software programs - Microsoft Word, PowerPoint, Excel, Project, Minitab
Effectively influencing and negotiating with all levels of an organization and leading effective/successful change initiatives

Senior Design Quality Engineer, Advanced Resume Examples & Samples

Understand how to take a user need to a quantifiable specification (ex. Force, output, time, etc.)
Identifies areas for improving intuitive use, usability of products through usability protocols, formative studies - executing studies with actual users (surgeon, nurse, technician, specialists)
Partners with PCBA manufacturers to give guidance for Design For Manufacturability and Design for Test design optimization
Candidate does not need to be proficient in all areas but must be proficient in some and be able to demonstrate being a quick learner
2+ years’ relevant job or academic experience
Hands on Electrical hardware engineering experience
PCBA, FPGA experience highly desired
Software or programming experience preferred but not required
Demonstrated pattern of technical innovation, collaboration, and creativity, inside and outside of previous job duties
BS in Electrical Engineering, Computer Engineering, or a related field
ASQ CQI, CQE, CRE, or P.E. desired but not required

Senior Design Quality Engineer APV Resume Examples & Samples

Bachelor’s Degree in Engineering or Science (Life Sciences, Physics, ME, EE, Industrial Technology, etc.)
2+ years related engineering experience with an M.S. degree
Extensive knowledge of quality tools

Senior Design Quality Engineer Resume Examples & Samples

4+ years of experience with a Bachelor’s degree
Ability to conduct hands-on technical work
Extensive knowledge and application of quality tools

Senior Design Quality Engineer Resume Examples & Samples

Product development team member focused on product development and life cycle management activities related to the Trauma/CMF business
Lead design and development planning activities for new and sustaining projects
Participate in all aspects of the creation and execution of functional/design requirements for new and sustaining projects
Conduct formal technical design reviews throughout the phases of the product development process
Support and approve design verification/validation activities including mechanical testing, tolerance analyses, design rationales, and surgeon based anatomical labs
Apply statistical methods and design excellence tools to design verification and validation activities
Support risk management activities including planning, design & clinical risk management, production risk management, and overall risk summary reporting
Lead the cascade of critical to quality design features to product quality plans and downstream manufacturing & quality processes. He/she will support transfer to manufacturing activities both in product development and base businesses
Enhance the design control and risk management processes to better reflect state of the art practices and drive continuous improvement
Provide leadership in all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconforming materials, risk management, and audit support functions
Provide leadership in the understanding of medical device regulations to other disciplines
Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Product Development, Regulatory, Manufacturing, and Marketing
A minimum of a Bachelor Degree in Engineering and/or in a Technical Science is required. A Master’s degree is a plus
A minimum of 4 years related working experience in a GMP and/or ISO regulated industry is required
Strong design/quality engineering skills with a proven track record in all aspects of the design control process, including functional/design requirements, design verification/validation, and product risk management is required
Previous experience in a medical device or a healthcare discipline is strongly preferred
Strong working knowledge of QSR (21 CFR 820) and ISO (13485, 14971) quality requirements is strongly preferred
Knowledge of process and design excellence tools is strongly preferred
An ASQ certification (CQE, CQM, CRE or CQA) is preferred. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is preferred
Candidate should possess excellent problem solving, decision-making, and root cause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations
Candidate should have a proven track record implementing Quality System improvements to meet compliance and overall business goals. Proficiency with the Microsoft Office Suite is required
This position will be based in West Chester, PA and will require up to 10% travel, including potential international

Senior Design Quality Engineer Resume Examples & Samples

Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulations
Assist in the creation of verification and validation test plans, protocols and reports. Oversee testing and analysis for standards and product requirements compliance
Ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques
Computer literate and experience with PCs, networks, and applications
Familiar with DMAIC or DMADV(DFSS) methodologies Desirable

Senior Design Quality Engineer Resume Examples & Samples

Take part in process improvement activities
Provide technical support and methods to assist production
Lead and solve any quality issue as required
Family with test plan and execution of test plan
Understand quality system requirements
Good English Skill and Mandarin skills
Positive attitude & good communication skills

Senior Design Quality Engineer Resume Examples & Samples

Provide technical and statistical reliability support to Product Development, Manufacturing and Quality organizations
Contribute to New Product Introduction Projects as a core team member and communicate activities to the extended team members of Quality
Support the product development teams in the adoption and use of best practices, Quality tools, and Design Control methodologies
Perform Risk Analysis including Fault Tree Analysis (FTA), Human Factors/Usability, and Failure Mode and Effects Analysis (FMEA) activities to ensure risks are identified and appropriately addressed
Monitor and develop reliability improvements to existing & new designs
Support Post Market Surveillance in the investigation of product complaints to determine the root cause and recommend appropriate corrective and preventive action to prevent recurrence
Work with other Groups to maintain an approved internal Quality System that meets the requirements of GMP’s, QSR 21 CFR Part 820 and ISO 13485
Evaluate quality data and prepare periodic reports to monitor trends
Generate, review and approve Engineering and Development Change Orders for Design Assurance

Senior Design Quality Engineer Resume Examples & Samples

Minimum of a Bachelor’s Degree in Engineering (HVAC&R product engineering experience preferred) with 5 plus years of experience in APQP, statistics, quality or related field
Experience in advanced quality, quality systems, problem solving skills (8D, CAPS, KT, etc.), product/project management and strong facilitation skills
Possess strong oral, written and listening communication skills and strong in team building skills
Experience in Verification, Validation, and Life Cycle Testing with Six Sigma (DMAIC) tools, Six Sigma Black Belt certification would be preferred, Design for Six Sigma (IDOV) experience would be desired

Senior Design Quality Engineer Resume Examples & Samples

Contribute to New Product Development projects as a core team member and communicate activities to the Regulatory Affairs and Quality extended team members
Provide effective quality engineering support for new product transitions into commercial production
Ensure clarity and consistency in acceptance criteria and that verification and validation processes used are capable
Provide technical and statistical reliability support to Product Development, Manufacturing, and Quality organizations
Lead major efforts, or phases of projects, to resolve complex technical and Quality-related problems
Provide effective support for multiple projects, balancing priorities and resources appropriately to meet both project and management expectations
Responsible for the assessment of technical standards against current DHF, labeling and technical file requirements to characterize gaps
Perform Risk Analysis and Failure Mode and Effects Analysis (FMEA) activities to ensure risks are identified and appropriately addressed
Support Risk Management activities to ensure design and process shortcomings are identified and appropriately addressed
Develop reliability improvements to existing & new designs
Work with other groups to maintain an approved internal Quality System that meets the requirements of QSR 21 CFR Part 820 and ISO 13485
Evaluate quality data and prepare periodic reports
Generate, review, and approve Engineering Change Orders for Design Assurance
Support corrective and preventive action activities related to product development and design change
It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem
Bachelor's Degree in Engineering or other similar Technical Discipline; or 4 years related experience
7+ years related Quality Assurance/Quality Engineering/Design Assurance experience
4+ years Medical Device Industry
ASQ Certification(s) a plus, Six Sigma experience highly desirable
Excellent working knowledge of FDA Quality System Regulation 21 CFR Part 820 and ISO13485 required
Excellent verbal communication and technical writing skills

Senior Design Quality Engineer Resume Examples & Samples

Support new product development and design through verification and validation activities
Support maintenance of existing products including but not limited to design changes, process changes, supplier changes, remediation, recertification and brand extensions
Function as a quality lead on multiple product development teams in matters relating to Quality Engineering
Ensure effective and efficient use of Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, and the development of sample plans
Lead and ensure the development of comprehensive risk management plans for the product, that critical design information is translated to the manufacturing site and that effective and comprehensive quality strategies/controls exist for the process
Communicate at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing
Provide guidance to project teams, suppliers and other disciplines to ensure compliance with company policies and procedures as well as medical device regulations
Lead investigation of quality issues and effective corrective and/or preventive action
Provide people leadership experience as this role may expand to have responsibility for a team of engineers
A minimum of a Bachelor’s degree in Engineering or related technical or scientific discipline with a minimum of 7+ years of experience in related field is required. A Master’s degree in a technical discipline is an asset
Excellent problem solving, decision-making, and root cause analysis skills are required
Interpersonal skills that foster conflict resolution are required
Experience with Blueprint reading/literacy including GD&T is required
Working knowledge of Design Controls, GMPs, QSR, 21 CFR 820, MDD 93/42/EEC, ISO13485 and ISO14971 quality
Previous experience in a medical device or a healthcare discipline is preferred
Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and design/process Failure Mode and Effects Analysis is preferred
Development and manufacturing experience is preferred
Knowledge of process and design excellence tools is strongly preferred. Process Excellence certification is a plus
Fluency in English is required, good knowledge of German would be a strong asset
Willingness to travel (10%)

Senior Design Quality Engineer Resume Examples & Samples

Experience in the facilitation of effective DMEAs/DFMECAs for complex electromechanical systems
Knowledge of Standards Applicable to Medical Device Safety/Risk Management (ISO 13485, ISO 14971, ISO 62303, IEC 60601-1, US 21 CFR Part 820, and related standards)
Experienced in the practical application of Systems Engineering and Systems Verification principles
Knowledge of Design Control Systems and ability to apply project management techniques
Experience with supplier management and component qualification practices
Experience managing a comprehensive risk management process for complex medical devices
Working knowledge of quality engineering principles, supplier management, and manufacturing operations within a regulated industry (preferably medical devices)
Proficient with utilization of quality tools (Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, FMEA, FTA, DOE, etc.)
Experience with Minitab or similar statistical analysis tools
Experience with Geometric Dimensional and Tolerancing (GD&T)
Fundamental understanding of electronic and electromechanical designs and manufacturing processes to support designing, troubleshooting, refining and qualifying the design to ensure the sustainable manufacturing of medical devices both internal and external

Senior Design Quality Engineer Resume Examples & Samples

Combination Product experience (development or manufacturing)
ASQ CQE or CQA
Familiar with regulations: FDA 21 CFR Part 820, Part 211, Part 4, ISO 13485

Senior Design Quality Engineer New Product Development Resume Examples & Samples

Bachelors Degree (B.S.) in mechanical engineering, mechanical engineering technology, biomedical engineering (or other technical degree applicable to position being filled) or related discipline from an accredited university and a minimum of seven (7) years related experience
Experience in product development with complex systems (mechanical, electrical, software, chemistry), including systems engineering and software design and development
Experience developing business processes and quality systems enhancements (product design through manufacturing) in a mature industry that has stringent quality regulations
Ability to constructively challenge designs and engage in transparent conversations
Ability to identify, analyze and solve problems with minimal direction and make decisions with confidence
Superior communication skills, both oral and written and ability to develop cross functional partnerships
High degree of initiative and self motivation. Strong analytical skills and the ability to solve problems through analytical reasoning
Proficient with Microsoft Office (Word, Excel, PowerPoint)
Overnight travel (up to 15%) may be required

Senior Design Quality Engineer Resume Examples & Samples

Provide ongoing quality engineering support throughout the product life cycle. Provide support to development, engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs and requirements
Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders
Identify areas and opportunities to improve quality system processes
Ensure product development and validation programs meet requirements of FDA and ISO when applicable
Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
Take initiative to identify and drive improvements to the Illumina quality system

Senior Design Quality Engineer Resume Examples & Samples

Evaluates product design and identifies potential design quality issues and drive technical decisions
Works within a development team to identify and implement effective controls to support the development, qualification, and commercialization of products to meet or exceed internal and external requirements
Accountable for ensuring Design Verification and Validation execution and deliverables comply with quality system regulations and internal requirements
Supports design test and inspection method development and validation
Ensures DHF and DMR content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
5-7 years of experience with a Bachelor’s Degree in a technical/engineering discipline; or
3-5 years of experience with a Master’s Degree in a technical/engineering discipline; or

Senior Design Quality Engineer Resume Examples & Samples

Bachelor of Science degree in Engineering, Physics, Biology, or similar
5 or more years of experience in a medical device company in a Quality or Compliance role, or 10 or more years of experience in a related role in a medical device company
Skilled in product risk assessment (ISO 14971), requirements management and tracing, defect tracking, and configuration management techniques
Understanding of current Quality techniques, industry standards (e.g. ISO, IEEE, CMMI), and FDA Quality System Regulations and their impact on internal procedures, quality, safety, and efficacy of products
Experience with standards for the design, verification, and validation of medical device products

Senior Design Quality Engineer Resume Examples & Samples

Actively represent Quality Assurance function on product/process project teams. - Mentor less senior Quality Engineers and quality technicians, including training, motivating, monitoring, and evaluation
Provide guidance to Engineering staff and other personnel and ensures that design control requirements are being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, and design review
Lead the investigation of complex product problems. Identify and manage corrective actions resulting from problem investigations
Master’s Degree in Engineering or Science (Life Sciences, Physics, ME, EE, Industrial technology, etc.)
Experience in the Medical Device Industry

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