Staff Engineer, Quality Job Description
Staff engineer, quality
provides competence in the areas of Quality Assurance, Regulatory Compliance, Design Controls, Risk Management, Equipment Qualification, Process Development, and Statistical Techniques.
Staff Engineer, Quality Duties & Responsibilities
To write an effective staff engineer, quality job description, begin by listing detailed duties, responsibilities and expectations. We have included staff engineer, quality job description templates that you can modify and use.
Sample responsibilities for this position include:
The Staff Quality Engineer partners with Enterprise Quality System organization to support the development, deployment, automation, and maintenance of a single set of standardized quality system processes and to create systems for compiling metrics and trending of customer complaints and adverse events to proactively identify product risks and trends
The Staff Quality Engineer provides leadership and support in execution of complaint vigilance processes and systems
Use Design & Quality Engineering tools for the New Product Development and Design changes to existing Products/Processes/Packages throughout the product lifecycle
Utilize Quality Engineering principles and problem solving skills to develop and optimize products/ processes that are aligned with the overall quality and business vision
This candidate must be able to communicate effectively at all levels within Quality cross-functionally with departments such as PD, Regulatory, Manufacturing, and Engineering
Establish and maintain quality assurance standards which adhere to Johnson and Johnson Quality requirements
Be responsible for the quality and regulatory compliance of products manufactured at Suppliers and External Manufacturers
Monitor quality performance of component suppliers and external manufacturers
Establish inspection and test methods for assigned product lines manufactured at suppliers
Perform process variability studies, Risk analysis, test method variability and establish sampling plans
Staff Engineer, Quality Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Staff Engineer, Quality
List any licenses or certifications required by the position: ASQ, CQE, ISO, CMMI, CQA, AS9100, 9001, III, CQT, ESD
Education for Staff Engineer, Quality
Typically a job would require a certain level of education.
Employers hiring for the staff engineer, quality 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, Computer Science, Math, Technology, Education, Electrical Engineering, Chemistry, Life Science
Skills for Staff Engineer, Quality
Desired skills for staff engineer, quality include:
Equipment qualification and design verification in the medical device industry
Regulated industries
Statistical Techniques
External business issues to improve products/services
Global environmental and social responsibility regulations/ standards and best management practices highly desired
Internal
Processes
Quality management system
Statistical analysis methods and techniques
Areas of Quality Assurance
Desired experience for staff engineer, quality includes:
Extensive Validation and Qualification experience is required
Must have outstanding business and technical communication skills (verbal, written, presentation)
American Society for Quality (ASQ) CQE, CQA, CMQ/OE, or equivalent professional credential is preferred
This position is located in West Chester, PA and may require up to 15% travel
A minimum of a Bachelor's degree is required, a degree concentration in Engineering, Life Science, Physical Science or a related field is preferred
Experience in statistical methods, and data analysis required
Staff Engineer, Quality Examples
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Staff Engineer, Quality Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of staff engineer, quality. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for staff engineer, quality
- Monitors complaint vigilance reporting modules for continuous improvement
- Ensures alignment of department objectives and activities with Business Quality Organization, Q&C, JSC and Enterprise Quality System strategic objectives
- Develops advanced technological ideas and guides their development into a final product, process or business opportunity
- Ensures the accurate and actionable recording of data for the making of decisions to document development work
- Plans and participates in disciplines strategically relevant to the business and/or functions
- Provides advice and mentors junior Associates
- Provide coordination and guidance to cross functional teams to ensure software quality objectives are met for product software, manufacturing software, quality system software, and software technologies included or used in the creation or production of medical devices
- Identify software quality challenges and software quality improvement opportunities
- Reviews and approves project documentation including Software Development Plans, Software Requirements Specifications, Software Design Documents, Software Test Plans/Protocols/Reports
- Conducts audits as member of a quality system audit team
Qualifications for staff engineer, quality
- A minimum of 7+ years of experience in Quality Engineering or Quality Assurance, including data analysis, risk assessment and risk mitigation is required
- Prior experience within an electro-mechanical environment is preferred
- A Six Sigma Green belt /Black belt certification is preferred
- Prior knowledge of medical device regulations such as 21 CFR 820 and ISO 13485 is preferred
- Understanding of continuous improvement methodologies including Lean, Six Sigma, SPC, is desired
- BS degree in Life Sciences or Engineering
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Staff Engineer, Quality Job Description
Job Description Example
Our company is looking for a staff engineer, quality. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for staff engineer, quality
- Support, perform, or oversee Internal and External Audits and CAPAs to ensure compliance with Quality Management System elements
- Conducts or leads internal audits and supports supplier audits
- Ensure that documented evidence exists to provide a high degree of assurance that specific design and processes will consistently and continually produce a product that meets specifications and critical to quality attributes
- Serves as the technical expert for the organization (worldwide) in the application of advanced theories, concepts, principles, and processes for an assigned area of responsibility (i.e., subject matter, function, type of facility, or equipment, or product)
- Develop or uses new techniques through literature research and collaborative means
- Represent QE Function as a project team member in various projects
- Provide the necessary details for costing of new products and generate and revise the Bill of Materials for all products
- Work with QC group to ensure understanding of and compliance with regulations, procedures, and requirements
- Identify gaps in GMP compliance
- Extensive application of technical principles, theories, concepts and quality sciences, tools, and systems with measureable / confirmed results
Qualifications for staff engineer, quality
- A minimum of 4+ years’ experience in an FDA regulated industry (medical device, pharmaceutical, ) is strongly preferred
- Extensive knowledge of applicable regulatory, Corporate and / or Unit requirements
- Hands on experience in design of experiments and statistics
- Class II / III medical device experience
- Extensive knowledge of design control principles
- Strong understanding and application of six sigma methodology preferred
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Staff Engineer, Quality Job Description
Job Description Example
Our growing company is looking for a staff engineer, quality. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for staff engineer, quality
- Perform Internal/External/Focused quality audits as needed by target timelines to assess the compliance to applicable regulations, standards and requirements
- Create and test applications and software frameworks to run and characterize/validate Big Data pipelines with a wide variety of data inputs, workloads, and APIs/interfaces
- Drive clarity and rigor in product definition
- Mentor junior software engineers and DevOps engineers
- Provide all planning necessary to ensure effective product acceptance
- Participate in MRB review of nonconforming product
- Design, Development and Quality Planning
- Risk Management / FMEA / FTA
- Quality Functional Deployment (QFD)
- Reliability, HALT/HASS Testing
Qualifications for staff engineer, quality
- Minimum of 8 years of Quality experience in the medical device industry
- Excellent knowledge of design controls and 21CFR820, ISO 13485, ISO 14971, ISO 10993, ISO 60601 and applicable medical device regulations
- Class II medical device experience required
- Develop and conduct training on Illuminas’s software life cycle framework to software developers testers and other stakeholders within the organization
- Provide CAPA support to software issues
- Contribute to software life cycle process improvements
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Staff Engineer, Quality Job Description
Job Description Example
Our company is looking for a staff engineer, quality. 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 staff engineer, quality
- QMS Monitoring - Lead development, deployment and oversight of metrics for the the NCM process at the site, regional, and global level to ensure appropriate monitoring of the health and compliance of the processes
- Audit Support - Support internal audits and host/support external audits and regulatory inspections
- Investigate nonconforming material and the determination of cause, corrective action and recommendation of disposition for the Material Review Board
- Other miscellaneous assignments including traditional Quality Engineer duties
- Lead or support Risk Management (in accordance with ISO14971)
- Develop and review validation protocols for effectiveness and compliance to Corporate Guidelines
- Knowledge of electrical systems, products, components, applications, component’s capabilities, electrical testing methods, testing finished products and system capabilities
- Provide coordination and guidance to cross functional teams to ensure product quality objectives are met
- Demonstrate functional knowledge and expertise in product development, verifications, validations, reliability, human factors, regulatory requirements, international standards, and risk management
- Process Validations
Qualifications for staff engineer, quality
- Knowledge of FDA requirements for design control of medical devices, particularly with verification and validation of software for medical electrical equipment, an asset
- Provide review and approval of software related change orders
- Ensure successful transfer of software from development into manufacturing product support
- Participate in software the risk management process throughout the entire software lifecycle
- Provide quality assurance support to software related CAPAs
- Identify and make recommendations for improvements to the Software Quality Assurance Program
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Staff Engineer, Quality Job Description
Job Description Example
Our innovative and growing company is looking for a staff 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 staff engineer, quality
- Support for the continuous improvement process of all supplier quality-related processes, guidelines and tools by means of internal audits, on-site assessments, and benchmarking and best practice sharing programs
- Maintenance of the defined Supplier Quality Management System (procedures, guidelines and tools), to ensure the requested quality is in line with the defined purchasing strategies in order to meet the cost, quality and productivity targets
- Ensures the day-to-day integrity of data generated by the QC Lab
- Receives new and/or updated equipment and test methods to support NPI and other business objectives
- Represents the QC Lab as an SME for the purposes of investigations, continuous improvement, and audits/inspections
- Provide subject matter expertise and ownership for Risk Management activities, including, the comprehensive and accurate assessment and characterization of design risks, which includes both the appropriate mitigation activities and proper identification in downstream design outputs (design failure modes and effects analysis [DFMEA], Critical To Quality and Critical To Process characteristics on specifications, Risk Assessments for issues impacting distributed product)
- Process Deployment and Continuous Improvement - Lead and drive innovative improvements to ensure global process deployment and effective implementation
- Process Documentation and Training - Development, management, oversight, and globalization of documentation and training materials
- Collaboration with Compliance, Supplier Quality, Human Resources, Operations and other applicable functions on QMS process & system strategies and best practices
- Lead regional and site quality system functional Subject Matter Expert knowledge, skill and process development, which includes identifying, defining and implementing improvements and best practices
Qualifications for staff engineer, quality
- Knowledge of six sigma methodology preferred
- Knowledge of design control principles (preferred)
- Bachelor's degree in Science related field, Quality Assurance, Engineering, Mathematics/Statistics or Related field
- Demonstrated proficiency with PC's
- Demonstrated experience in the effective application and meeting requirements of FDA 21 CFR Part 820 QS regulations and ISO 13485/ 14971 standards, CE regulations
- Basic understanding of principles of finance