Senior Engineer, Quality Job Description
Senior engineer, quality
provides expert interpretation and application of regulatory guidelines to ensure operations, facilities and documentation meet Roche standards and regulatory requirements.
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:
Establishes testing metrics as required by the QA Standards
Documents deviations from the established procedures and standards
Drive Regional Quality objectives throughout the business
Work collaboratively with design engineers providing guidance and participation in design inputs, design and development planning, design reviews, design verification and validation, and design transfer efforts
Ensuring the necessary training and support is made available to the department and other functional areas
Validates equipment/process/product changes from a quality standpoint
Through analysis of Performance Data, identify performance gaps, trends and improvement opportunities
Support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
Complete non-conformances, CAPAs, Change Management and Batch Release related to FG/EM suppliers within required timelines
Provide technical mentorship and resolve quality supply chain issues with the company's EM suppliers
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:
Statistics and the interpretation of statistical results
MS Office and their application
Quality Engineering processes and regulatory requirements
GMP guidelines
ICH Q7
Q10 and other international regulatory requirements
Q8
Validation Lifecycle Approach
FMEA
Desired experience for senior engineer, quality includes:
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues with EM suppliers
Assist with Quality Assurance functions, supply chain and R&D organizations in sourcing new FG / EM suppliers
Drive and implement process improvements to ensure predictable processes across all product lines
Ensure Regulatory compliance in area of responsibility to all medical device regulatory agencies
Provide functional expertise to other support functions on quality related issues
Champion key Quality Metrics for the Quality project team CAPA, Quality Incidents, manufacturing complaints, RFT, Audit results Identify and drive improvement opportunities
Senior Engineer, Quality Examples
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Senior Engineer, Quality Job Description
Job Description Example
Our company is searching for experienced candidates for the position of senior engineer, quality. 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 senior engineer, quality
- 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
Qualifications for senior engineer, quality
- 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
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Senior Engineer, Quality Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of senior engineer, quality. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for senior engineer, quality
- 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
Qualifications for senior engineer, quality
- 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
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Senior Engineer, Quality Job Description
Job Description Example
Our company is hiring for a senior engineer, quality. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for senior engineer, quality
- 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)
Qualifications for senior engineer, quality
- 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
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Senior Engineer, Quality Job Description
Job Description Example
Our company is searching for experienced candidates for the position of senior engineer, quality. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for senior engineer, quality
- 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
Qualifications for senior engineer, quality
- 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
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Senior Engineer, Quality Job Description
Job Description Example
Our company is growing rapidly and is hiring for a senior engineer, quality. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for senior engineer, quality
- 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
Qualifications for senior engineer, quality
- 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