Development Quality Engineer Job Description

Development Quality Engineer Job Description

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Development quality engineer provides strategic and tactical leadership of Quality Engineering Function, based on understanding of 21 CFR Part 820 and ISO Requirements.

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:

Lead the development of the product Risk Management Plan and maintain customer specified content of the Risk Management File for each unique product
Assist in Notified Body Audits, FDA inspections and other 3rd party audits
Define and Develop Critical to Quality standards that address Customer Wants and Needs
Lead to Develop Critical to Quality standards that address target Customer wants and needs
Strong interpersonal skills and have the ability to work well with cross-functional teams to deliver win-win results
Lead Quality Improvement initiatives with supplier and Ford manufacturing facilities to improve quality
Be responsible for test plan development execution
Build and add new tests and automation frameworks
Streamline, audit and ensure software test and delivery pipelines are optimized
Collaborate with dev teams, identify and prioritize opportunities for automation

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:

ISO 13485
GMP
FDA
FDA 21 CFR Part 820
21 CFR part 820
IEC 62304
Quality information systems
Risk Management

Desired experience for development quality engineer includes:

Knowledge of Robust Engineering Fundamentals
Self-motivated, capable of providing a clear vision for success, and motivated to deliver results
Working knowledge of Microsoft Office (Excel, Word, PowerPoint, Minitab or Statistical tools)
Bachelor’s Degree in Engineering or obtained prior to August 2015
Plans, prepares, moderates and performs reviews in line with the project quality strategy
Assists the project team in realization of the processes in their day to day business

Development Quality Engineer Examples

1

Development Quality Engineer Job Description

Job Description Example
Our company is growing rapidly and is looking for a development 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 development quality engineer
  • 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
Qualifications for development quality engineer
  • 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
2

Development Quality Engineer Job Description

Job Description Example
Our innovative and growing company is hiring for a development 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 development quality engineer
  • 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
Qualifications for development quality engineer
  • 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
3

Development Quality Engineer Job Description

Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of development 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 development quality engineer
  • 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
Qualifications for development quality engineer
  • 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
4

Development Quality Engineer Job Description

Job Description Example
Our company is searching for experienced candidates for the position of development 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 development quality engineer
  • 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
Qualifications for development quality engineer
  • 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…)
5

Development Quality Engineer Job Description

Job Description Example
Our company is looking to fill the role of development quality engineer. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for development quality engineer
  • 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
Qualifications for development quality engineer
  • 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)

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