Senior Engineer, Quality Job Description
Senior Engineer, Quality Duties & Responsibilities
To write an effective senior engineer, quality job description, begin by listing detailed duties, responsibilities and expectations. We have included senior engineer, quality job description templates that you can modify and use.
Sample responsibilities for this position include:
Senior Engineer, Quality Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Senior Engineer, Quality
List any licenses or certifications required by the position: ASQ, CQE, ISO, CQA, NASA, CQT, AS9100, ISO9001, UK, TS
Education for Senior Engineer, Quality
Typically a job would require a certain level of education.
Employers hiring for the senior engineer, quality job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and University Degree in Engineering, Technical, Science, Computer Science, Education, Manufacturing, Industrial, Medical, Mechanical Engineering, Management
Skills for Senior Engineer, Quality
Desired skills for senior engineer, quality include:
Desired experience for senior engineer, quality includes:
Senior Engineer, Quality Examples
Senior Engineer, Quality Job Description
- Lead Nonconforming Material process (NCMR) including investigation, analysis and chair of the material review board
- Complete assigned Quality Engineering tasks to schedule
- Promote awareness of Quality and Regulatory requirements
- Lead or participates in the development of process and procedure development/changes
- Develop new approaches to solve problems identified as part of the team
- Train location personnel on all aspects of the Quality System and regulatory standards
- Serve as a mentor for the Quality team to assist in developing Quality Engineering skills
- Apply the requirements of the Quality System to processes, products or services for the location
- Support the manufacturing line to address quality issues and resolution
- Provide support to metrology and preventive maintenance programs
- Experience writing automated functional, and regression test cases, with a sound understanding of CI/CD processes
- Experience testing native mobile apps (Android studio and Xcode) is a plus
- Experience working on Ruby/Ruby on Rails is a plus
- Ability to work well in a team with a positive
- Proficiency in Microsoft Office suite and statistical programs
- Professional certification, American Society of Quality Certification in Quality Engineering or Reliability, Six Sigma Black Belt, Master Black Belt preferred
Senior Engineer, Quality Job Description
- Provide guidance and/or training to Quality Inspectors, Technical or Engineering resources in good measuring practices
- Perform measurement data analysis to make statistically inference on the capability of the parts, sub-assemblies or finished product devices to meet defined specifications
- Perform equipment, test method and software validations in compliance with the company’s procedures and regulatory requirements
- Partner with suppliers, Research and Development (R&D), Process Engineers and other cross functional teams to evaluate dimensional issues and define and implement actions to effectively address them
- Continually improve the company’s product quality engineering processes while improving technical expertise and understanding of regulatory requirements
- Identify, recommend and implement initiatives for the continuous improvement of processes
- Integrate and analyze applicable Quality System Indicators, product process indicators and provides feedback to the plant CAPA system
- Influence and evaluate the design for the manufacturing of new product processes to be transferred while developing applicable quality plans
- Support or lead quality improvement initiatives such as process and product characterizations that lead to continuous/cost improvements
- Provide Quality Assurance Engineering (QAE) and technical consulting to corporate, plant, and Research & Development as needed while utilizing a Project Tracking Sheet
- Knowledge of basic mechanical testing and material properties is necessary
- Knowledge of metrology is essential
- Background and familiarity with U.S. FDA QSR, requirements including ISO 9001, MDD 93/42, ISO 13485-2003, and Canadian Medical Device requirements is necessary
- Working knowledge of problem solving skills is essential
- Good statistical and analytical skills are desired
- Working knowledge of Problem Solving Tools is necessary
Senior Engineer, Quality Job Description
- Review code changes as they are made to become familiar with the implementation in order to have a focused testing approach
- Help Development when debugging issues by providing as much detailed information as possible
- Maintain the issue backlog and work with Development and Product to prioritize and include fixes within subsequent releases
- Connect with Site Quality Engineers and Support Engineers to understand existing production issues and modify testing strategies to incorporate cases to prevent reoccurring production issues
- Provide technical leadership and mentoring for more junior QE
- Analyze requirements, develop automated tests and test strategies, and track defects for the unified device management platform
- Participates in development/documentation of design-bid-build and design-build proposals
- Participates in technical and constructability reviews and coordination efforts throughout the design process, in coordination with Project Managers, to ensure that high standards of quality are achieved
- Designs and implements drawings, specifications, and other design documentation in conjunction with the project manager and other design team members
- Lead and support cross-functional failure investigations to identify root cause and corrective and preventative action utilizing advanced problem solving tools (8D, 5 Why, K-T, DMAIC)
- Understanding of Lean Manufacturing principles, experience with Kaizen events or experience with a continuous improvement program (ACE, 6σ)
- Bachelor degree in Industrial, Mechanical or Chemical Engineering
- Support deployment of internal development procedures including Design Control, Risk Management, Post Market Surveillance, and Statistical Techniques to the product development teams
- Proficient in use of statistical analysis and associated tools
- BS in Engineering (or equivalent) and a minimum of 7-10 years' experience in Engineering required
- Experience with ISO 9001 or 13485 required
Senior Engineer, Quality Job Description
- Communicate significant issues or developments to management and recommend corrective/preventative actions
- Support the manufacturing strategy and footprint for plant
- Communicate significant issues or developments to management and recommend corrective/prevenative actions
- Develop, maintain and execute automated and manual test scripts for functional and nonfunctional requirements validation, integration, regression, performance and usability testing
- Follow quality assurance standards and track quality assurance activities
- Create test strategies, test estimation and all planning activities
- Draft test artifacts, including Test Plans, Test Scenarios and Requirements Traceability Matrices
- Test Environments and tools management
- Work closely with customers to understand product quality issues and resolving the issues in a timely manner
- Partner with operations to reach perfect execution
- Full understanding of the quality system
- Ability to use inspection tools, measuring and test equipment
- 2 - 5 years of progressive experience within the manufacturing industry
- Continuous improvement certificate preferred
- Certification or licensure within a quality program or body of knowledge is preferred
- Direct experience working as a customer contact for automotive OEMs
Senior Engineer, Quality Job Description
- Ensure that Test Methods and Quality procedures are executed in compliance with specifications and standards
- Subject Matter Expert for Quality Engineering subjects during audits
- Provide guidance to project teams and business partners to ensure compliance with company policies and procedures medical device regulations
- Supports the development of quality strategies related to the transfer of products, materials and components within J&J or externally
- Ensure effective quality strategies for Process, Test Method and CSV validation
- Monitor quality data and metrics on a regular basis to that ensure appropriate investigation, correction action, and/or escalation is conducted as required for recurring trends
- Participate on cross-functional new product development teams with focus on the execution of quality plans and design transfer
- Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis
- Initiate and/or participate in process and product corrective actions and problem solving activities
- Constantly review the current quality system and recommend / implement improvements as needed
- Proficient in SPC & Six Sigma methodology and tools
- Able to create Multi-source report, trends, and interprets data with minimal oversight
- Uses data to quantitatively communicate problem or issue
- Understands typical Excel data analysis operations
- Able to plan complex project with cross functional team, coordinates and prioritize tasks with minimal oversight
- Able to advise Peers