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Quality Engineer
Irvine, CA, US
Engineering
Bachelors Degree
Full Time, Temporary
Experienced (Non-Manager)
On-site
Medical Devices and Supplies
First Shift (Day)
Irvine, CA, US
Experienced (Non-Manager)
Full Time, Temporary
Medical Devices and Supplies
On-site
Engineering
Bachelors Degree
First Shift (Day)
Job details
Kelly Science, Engineering, Technology, and Telecom, a managed solution provider and business unit of Kelly Services, is seeking Quality Engineers for a long-term Hybrid contract with one of our global medical device clients in Irvine, CA.
Our Client is a global leader in the science of diagnosing and treating heart rhythm disorders. Established their leadership in electrophysiology with the development of the first real-time, 3D cardiac mapping and navigation technology, as well as the first electrophysiology catheter.
Join a Leading Innovator in Cardiac Care and Device Development
The Quality Engineers will be supporting the transfer between NPD and Manufacturing. Hybrid 2 days on-site one week, 3 days on-site the next…there will be times when they need to be on site 5 days when there is testing.
The Quality Engineer – plans, coordinates and executes quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product. Involved in New Product Development (NPD) teams and other activities to develop products, design verification tests, process validations and quality processes to ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards. As needed, assists to develop quality-engineered systems and products, and support qualification and validation activities. Will be considered a subject matter expert (SME) on Quality matters, relevant Quality tools and will work on complex problems and projects. Will show leadership in driving program/projects and innovating compliant approaches and solutions to problems. Shares technical expertise with others and develop other engineers. A few of the responsibilities may involve collaborating with other members of the Design Team. Will contribute to activities including risk management document development, creation, and design of catheter test methods, authoring of test protocols, and testing of products during their development cycle.
DUTIES & RESPONSIBILITIES
• Working with other functional groups, including R&D and Operations in support of new product development, engineering projects, quality assurance activities, and lifecycle management.
• Utilizing Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
• Oversight, from a Quality NPD perspective, of the Non-Conformance Report (NCR) process for the facilities located in the U.S.
• Develop and establish effective quality control and support associated risk management plans, AFMEA, DFMEA and PFMEA.
• Write, review and/or approve process and product validation protocols and reports, equipment qualifications, engineering change orders.
• Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, Statistical Process Control (SPC), Design of Experiments (DOE), etc.). Performs statistical analysis of data generated including but not limited to: Gauge R&R, ANOVA, Sample Size determination and variable/attribute data analysis against predetermined acceptance criteria.
• Ensure that development activities follow design control requirements (Design Trace Matrix), product is tested per applicable standards, GSPR are met per the MDR, and product is properly transferred to manufacturing per applicable specifications.
• Technical problem-solving, failure analysis, and root cause determination.
• Makes decisions independently on engineering problems and methods and represents the organization in conferences to resolve important questions and to plan and coordinate work.
• Plans, develops, coordinates, and directs one or more large important engineering projects or a number of small projects with many complex features.
• Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment, when necessary, data are insufficient or confirmation by testing is advisable.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES
• Bachelor’s degree, required; preferably in engineering or scientific discipline
• 4-5 years of quality engineering experience.
• Catheter experience or class 3 delivery preferred
• Experience in design transfer – DBT (testing of finished devices)
• Process / equipment investigations
• CAPA experience a plus
• Manufacturing, or research and development experience in a medical device or other regulated industry
• Ability to define problems, collect and analyze data, establish facts, and draw conclusions and recommendations
• Ability to develop and implement Quality standards
• Demonstrated auditing and problem-solving skills
• Knowledge of leading-edge Quality Engineering, design control, and verification and validation (V&V) tools and methodologies
• Ability to effectively collaborate and communicate with internal and external partners at all levels of the organization.
• Understanding of theoretical and practical fundamentals and experimental engineering techniques such as DOE, DMAIC and ANOVA is a plus.
• Working knowledge of SolidWorks, other CAD-based programs (ie. basic dimensioning, tolerance stack analysis) is a plus.
• Six Sigma/ Design for Six Sigma experience, and/or knowledge of Process Excellence tools is a plus.
• Ability to define problems, collect and analyze data, establish facts, and draw conclusions and recommendations
• Ability to use broad knowledge of regulatory, technical, and business requirements to conduct due diligence assessments
• Ability to apply project management skills to ensure fulfillment of new product development requirements
• Ability to develop and implement Quality standards
• Demonstrated auditing and problem-solving skills
• Knowledge of leading-edge Quality Engineering, design control, and verification and validation (V&V) tools and methodologies
• Ability to effectively collaborate and communicate with internal and external partners at all levels of the organization including influencing and negotiating resulting in positive business and quality outcomes.
• Understanding of theoretical and practical fundamentals and experimental engineering techniques such as DOE, DMAIC and ANOVA.
• Six Sigma/ Design for Six Sigma experience, and/or knowledge of Process Excellence tools
• Lean manufacturing experience
• Knowledge of Quality and operations systems and processes, including GMP
• Working knowledge of CAD software (Solidworks, AutoCAD) Working knowledge of SolidWorks, other CAD based programs (i.e.. basic dimensioning, tolerance stack analysis) is a plus.
• Experience with Minitab, R and other statistical software is a plus.
• Geometrical Dimensioning and Tolerancing (GD&T) experience with an understanding of ASME Y14.5.
Key Responsibilities:
• Utilizing Design Quality Engineering tools/processes in the development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
• Leading efforts for continuous quality and customer satisfaction improvement opportunities.
• Support the Non-Conformance Report (NCR) process for facilities located in the U.S.
• Develop and establish effective quality control and support associated risk management plans, AFMEA, DFMEA and PFMEA.
• Write, review and/or approve process and product validation protocols and reports, equipment qualifications, and engineering change orders.
• Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, Statistical Process Control (SPC)
• Design of Experiments (DOE), etc.
• Ensure that development activities follow design control requirements (Design Trace Matrix), product is tested per applicable standards, GSPR is met per the MDR, and product is properly transferred to manufacturing per applicable specifications.
• Technical problem-solving, failure analysis, and root cause determination.
• Makes decisions independently on engineering problems and methods and represents the organization in conferences to resolve important questions and to plan and coordinate work.
• Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment.
• Assigns/reviews quality inspection testing and test data.
• Keeps department supervisor abreast of activities and issues of the quality group.
• Responsible for communicating business-related issues or opportunities to next management level
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States immediately and without employer sponsors
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