Development Quality Engineer Job Description
Development Quality Engineer Duties & Responsibilities
To write an effective development quality engineer job description, begin by listing detailed duties, responsibilities and expectations. We have included development quality engineer job description templates that you can modify and use.
Sample responsibilities for this position include:
Development Quality Engineer Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Development Quality Engineer
List any licenses or certifications required by the position: ASQ, CQE, CQA, TS16949, ISTQB, SQE, CSQE, CQT, IRIS, ISO
Education for Development Quality Engineer
Typically a job would require a certain level of education.
Employers hiring for the development 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, Technical, Electrical Engineering, Education, Science, Mechanical Engineering, Computer Science, Manufacturing, Biomedical Engineering, Business
Skills for Development Quality Engineer
Desired skills for development quality engineer include:
Desired experience for development quality engineer includes:
Development Quality Engineer Examples
Development Quality Engineer Job Description
- Actively participates on cross-functional design teams reviewing design documentation for quality characteristics including product requirements, risk management, verification/validation, manufacturability, serviceability and packaging
- The candidate will assists the Dir., Quality Assurance in the training and/or the preparation of training material for other departments, as required, and assist the Dir
- Continuing to build out the CI/CD pipeline
- Developing automation tests at multiple levels (unit, contract, integration, UAT)
- Conducting training and consultation with feature teams
- Driving Agile practices for collection, analysis, and presentation of metrics related to QE
- Facilitate documentation of functional, electrical and mechanical specifications
- Lead product Risk Analysis meetings and document the results as specified in ISO 14971
- Coordinate device reviews with safety agencies
- Coordinate all Design Verification Test activities, including generation of the verification Plan, Procedures and Report documents
- Record evidences of quality assurance activities
- Assists the team with resolution on non-conformances
- Checks compliance of product engineering processes evaluates effectiveness and efficiency of processes and
- A minimum of a Bachelors’ Degree is required, preferably in a technical discipline, an advanced degree is preferred
- A minimum of 6 years’ experience in a highly regulated environment is required
- Process Excellence/Lean experience is preferred
Development Quality Engineer Job Description
- Identify test cases for automation and automate test cases as necessary
- Execute both manual and automated test cases, analyze test results to determine pass/fail status, and report results in a consistent manner
- Design and develop test harnesses, web apps, and web pages
- Engage in the further development and implementation of the TD Materials Quality Business Process
- Ensure accurate materials usage data compilation and readiness of data transfer using PRISM
- Provide consulting and assistance to Engineering and Procurement teams for identification of best known quality practices and materials selection
- Develop relationships to achieve new ideas and procedures to keep pace with Industry standards and methods
- Serve as the TD liaison for global supplier quality projects, processes, and initiatives
- Maintain centralized quality documentation
- Compile information and distribute to partner groups and suppliers
- 1 year experience in a manufacturing or production environment
- Exposure to 3D modeling and design software
- Experience with new project or program development activity
- ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA)
- Bachelor's degree or equivalent experience in business, software engineering or computer science
- At least 4+ years of management and technical experience in software development environment
Development Quality Engineer Job Description
- Serve as the TD liaison for quality escalations, issue resolution, and improvement activities
- Review and approve Supplier Change Management notifications
- Review and approve Chemical Requests
- Team with Corporate Procurement to generate global specifications for FOAK materials
- Work with Micron and supplier labs to develop materials analytical requirements and method
- Provides quality system methodology guidance, support and review for medical device products throughout the design, development and change control processes
- Reviews, approves and provides input as necessary to assist R&D in the creation of verification and validation plans, protocols and reports
- Participates in product risk assessment efforts within product teams and updates to existing product lines
- Provides support to facilitate resolution of product complaints and/or safety issues
- Participates in problem solving efforts to identify and resolve quality issues to ensure production of safe and effective medical devices
- Experience with bug tracking systems, Jira, Bugzilla, Trac
- Assure quality of release procedure and baselines (System, Hardware, Mechanic, Software)
- Minimum of 2 years of Java and/or C++ development
- Demonstrated ability to work well in a team setting with people from a wide range of backgrounds
- Received a M.S
- Experience testing and managing team of engineers that perform testing of web based software in SAAS architecture
Development Quality Engineer Job Description
- Auditing IC and SW projects and subcontractors creation processes and quality systems
- Drive systematic improvements in the development process internal at subcontractors (supplier quality management)
- Provide backroom support for 3rd Party Inspections and Audits
- Solve the customer’s complaint effective
- Executing validation on new/repaired Mold
- Improve quality issue during the production
- Ensure product success by assessing design and process against customer and Sensata requirements throughout NPD
- Fulfill our customers’ Quality System requirements (APQP, VDA)
- Reviews Engineering Change Requests for their impact on Quality & Reliability
- Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product
- Good understanding of manual and automated testing of applications and automation frameworks
- Specific experience in Agile software development, particularly in Scrum and Scrum Master role
- Knowledge of test process, testing techniques, and software test tools
- Ability to work with cross-functional teams or with minimal supervision
- Ability to occasionally work flexible hours to accommodate global sites
- Quality tools experienced (FMEA, Design of Experiments, Control Plan, PDCA, 8D…)
Development Quality Engineer Job Description
- Point of contact for engineering quality
- Point of contact for all product related incidents ensure delivery of third party quality metrics
- Must have a proven track record of developing and executing standardization
- Manage projects which may include new production equipment, process improvements and cost reductions while supporting new product introductions
- Maintains knowledge of the developing clinical environment
- Support objective component specification definitions, supplied component sampling plan development, and vendor qualifications • Support execution of biocompatibility and sterilization qualifications • Complete Document Change Request Reviews in a timely and objective manner
- Tracking, trending and reporting of Quality issues on a monthly basis will be required
- Writing of Exception Reports and CAPA plans performing Compliance audits will also be expected
- Ensure compliance to QMS and design control processes and procedures
- Contribute to the development and refinement of Design Control policies and procedures to ensure they comply with appropriate standards, regulations, and industry best practice
- A Bachelor's degree in an engineering, scientific or equivalent background is required for this position
- Experience of 2 years in medical device product development or equivalent is required for this position
- Possess a strong working knowledge of medical device development
- Experience with Design Verification activities including test planning, test procedure and test report development
- Experience working with safety agency test labs (NRTLs) for agency certifications such as UL, CSA, CE, is a plus
- Bachelor’s degree in in Engineering (prefer Mechanical or Biomedical) and 5+ years of experience (CQA or RABQSA, CQE or CmfgE certification required)