Design Quality Engineer Job Description
Design quality engineer
provides strategies, guidance and training to teams on requirements of 21 CFR 820 and ISO 13485 with particular focus on Design Controls, Document Controls, Risk Management (per ISO 14971) and Production and Process Controls.
Design Quality Engineer Duties & Responsibilities
To write an effective design quality engineer job description, begin by listing detailed duties, responsibilities and expectations. We have included design quality engineer job description templates that you can modify and use.
Sample responsibilities for this position include:
Participates in Risk Management activities throughout product lifecycle
Perform quality activities (risk management, FMEA, creation of documents, document review) according to project schedule
Use statistical and risk management techniques for design and manufacturing and medical device industries
Lead the Appearance Approval Process and Final Color Harmony (start to finish) on multiple programs from initial Studio Feasibility (Interior / Exterior) Checkpoints, Color & Materials - Mastering, Tier 1 Supplier Part reviews, and NA Assembly Plant reviews until OK to Buy has been achieved
Lead multiple program Color Harmony launches at all North American assembly plants to ensure all appearance parts meet the Minimum Appearance Standard AAR approval
Participate and sign off on all appearance part Mold Flow analysis
Ability to understand complex injection, compression tools, stamping tools, and give specific direction to improve quality issues
Drive the Color Harmony Teams (Program Management), Vehicle Operations – Global Paint Engineering, New Models Teams, Raw Material and Tier 1 suppliers to ensure each appearance part has met all Color Harmony Requirements including Material Color / Durability Compliance Certification
Lead and resolve all Color Harmony Final Appearance issues with all Raw Material & Tier 1 suppliers
Frequent travel is required to support all assembly plants in the USA, Canada and Mexico
Design Quality Engineer Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Design Quality Engineer
List any licenses or certifications required by the position: ASQ, CQE, CSQE, CRE, CQA, ISO13485, QA, ISO, DFSS, CAPA
Education for Design Quality Engineer
Typically a job would require a certain level of education.
Employers hiring for the design quality engineer job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Science, Technical, Education, Medical, Mechanical Engineering, Computer Science, Life Science, Design, Physical Science
Skills for Design Quality Engineer
Desired skills for design quality engineer include:
ISO 13485
Design Controls
Medical Device Directive
QSR
FDA
Risk Management
IEC 62304
Process and design excellence tools is strongly
21 CFR 820
Desired experience for design quality engineer includes:
Apply statistics and process/design excellence tools to establish test plans and evaluate data and processes
Experience in related areas, R&D or Manufacturing may also be applicable if experience includes work responsibilities listed above
Working knowledge of various Software Development Life cycle (SDLC) models
Minimum (7) seven years’ experience in design, manufacturing or quality engineering position (medical device experience preferred)
Master's degree in Software Engineering, Computer Science, Computer Engineering or Electrical Engineering •Previous experience working in a cross-functional team environment
Experience with analytical tools and methods, including statistics (Minitab preferred), DOE, and the use of computer software packages related to design, development, and manufacturing
Design Quality Engineer Examples
1
Design Quality Engineer Job Description
Job Description Example
Our growing company is looking for a design quality engineer. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for design quality engineer
- Supports ISO 14971 compliance and leads in the implementation and development of product risk management tools
- Executes the site Quality Management System including CAPA, Internal/External audits, Management Review, Calibration, Maintenance, Training and other aspects to support and maintain certification of ISO 9001 other certifications
- Review of project schedules for compliance to design procedures and customer requests
- Works closely with R&D and Technical Transfer teams, contributing to developing quality specifications for new products
- Active team member in the development and updates of products dFMEA
- Establish appropriate attribute/variable parameters for a range of new products/systems and establish consistent methodology for quality control testing and quality assurance
- Develops and implements intermediate and advanced problem solving tools
- Develops and initiates quality plans, standards and methods for inspection, testing, and evaluation
- Supports/performs validation activities associated with both new and/or changed products, and maintains all associated supporting documentation for engineering protocols and reports
- Performs light mechanical design for quality gages and fixturing, reliability analysis, problem solving and continuous improvement activities
Qualifications for design quality engineer
- Experience in medical device software and/or software in the GMP domain
- Understanding of IEC-60601, IEC-62366
- Maintain traceability between requirements, specifications and test reports
- Review applicable standards, if necessary with external test houses or certification bodies
- Responsible for external safety and EMC tests
- Ensure that all applicable standards will be covered, if necessary with external test houses or certification bodies
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Design Quality Engineer Job Description
Job Description Example
Our company is looking to fill the role of design quality engineer. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for design quality engineer
- Communicates with suppliers about inspection and test results of prototypes
- Analyzes Non-conformance event and complaint data analysis, investigates root causes, proposes improvements, and maintains NCE / CAPA documentation
- Continuously drives a culture of continuous improvement, reinforces the elimination of variation and supports business improvement and profitability
- Participates in assessment teams in applying quantitative tools to identify the current state from which improvement opportunities exist
- Communicates project progress, capture cost savings, consumer satisfaction, or other appropriate business productivity metrics to direct supervisor
- Documents data obtained during all quality activities using good documentation practices
- Communicates significant issues or developments identified during quality activities and provides recommended process improvements to direct supervisor
- Coordinates project work among the cross-functional project participants ensuring clear accountability and understanding of the project work, roles and responsibilities
- Establishes the mechanism to track and communicate project progress, capture cost savings, consumer satisfaction, or other appropriate business productivity metrics
- Develops gauging applicable to products and tolerance as needed
Qualifications for design quality engineer
- Understanding of coding and development principals
- 8-10 years of experience in Tool Texturing of Injection Molds and Compression Molds
- 7+ years experience in product development or quality engineering in the medical device industry
- Blueprint and specification reading
- At least 8 years work experience in Quality or related filed experience
- Bachelor Degree in Electrical or Mechanical Engineering, Masters of Engineering a plus
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Design Quality Engineer Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of design quality engineer. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for design quality engineer
- Internal coordination/liaison with development team to ensure appropriate control and introduction of any proposed changes to products and systems
- Train, coach, mentor and motivates subordinates in Lean/Six Sigma tools/techniques as required
- Shares lessons learned/best practices across multiple departments and locations
- Supports opportunities to improve manufacturing/design processes, , lean techniques and optimized scale up
- Assists in preparation and updates of quality procedures, work instructions and other documentation
- Active member of SBUs internal audit team
- Prepares audit plans, checklists, performs audit as required and prepares audit report
- Initiates corrective and preventive action (CAPA) plans with root cause analyses
- Active participation and support of the internal audit process
- Drive corrective, preventive, and closure actions for project issues related to quality and/or test nonconformance
Qualifications for design quality engineer
- Minimum 2 years engineering work experience with exposure to manufacturing processes and concepts
- Home Appliance product knowledge
- Minimum 5 years full time experience in a Lean Six Sigma Quality engineering role
- Extensive knowledge of product design activities
- Three (3) years of practical medical device manufacturing experience is preferred
- Good working knowledge of upstream product development and validation experience, including protocol development
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Design Quality Engineer Job Description
Job Description Example
Our company is looking for a design quality engineer. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for design quality engineer
- Ensure the implementation of Risk Management activities during product development
- Understand the processes and intent of all aspects of the QMS related to Design Controls
- Perform data analysis, develop and track trends, develop and maintain quality reports, draw conclusion, and drive action for monitoring and improvement of the quality of our products’ design
- Works collaboratively with other engineers to implement design improvements
- Participate in on-going quality activities, pertained to product design and quality assurance
- Develop customer Intimacy in front of his/her OEM (Original Equipment Manufacturer) counterpart
- Apply perceived quality process from early phase to tool release
- Apply product (shape and appearance) approval process from tool release to pre-production inside our Design quality process
- Contribute actively to the design quality expertise development
- Work closely with product development engineering, clinical, marketing, regulatory, and other business partners to assure appropriate quality requirements are defined for the specific device application and target patient population
Qualifications for design quality engineer
- Test method development and documentation
- Experience with ASTM methods
- Knowledge of Six Sigma methodology, SPC techniques and MINITAB data analysis
- Proficient in Microsoft office/windows applications
- Knowledge of lab equipment, instruments and calibration procedures
- Detailed oriented, high energy, self-starter, who exercises sound judgment and deliver against company business goals and objectives
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Design Quality Engineer Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of design quality engineer. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for design quality engineer
- Ensure completion of the functional actions items /tasks and submission of deliverables to the document control system and report on functional group progress to team (including escalation and program review)
- Participates in the defects classification, defect risk analysis and investigations
- Participates in reviews related to design, validation, defect classification and documentation as required
- Support program managers with identification and maintenance of program team interdependencies
- Work with the design team to ensure that standard operating processes are used correctly and maintained during the development process
- Ensure that the project data and documents are managed according to the control management documents and procedures
- Act as Change Analyst for Product Configuration Management and Release
- Record and completes documents relevant to QA
- Provide support to clients in quality assurance activities
- Participate in ISO certification, conduct auditing and client audits
Qualifications for design quality engineer
- Exposure to general manufacturing environment
- This position may come in contact with hazardous material such as blood borne pathogens
- BS in Electronics or Computer Science
- MS is a plus RF and Software/Firmware development understanding ISO
- Knowledge Write and speak English 90%
- Ability to speak on public (on English and Spanish)