Kelly Science, Engineering, Technology, and Telecom , a managed solution provider and business unit of Kelly Services, is seeking Design Quality Engineers for a long-term 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
Th e Design Quality Enginee rs will be supporting the transfer between NPD and Manufacturin g. 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
Key Responsibilities
• Utilizing 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 US
• 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 )
• 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 ensuring personal and Company compliance
• Performs other duties assigned as needed
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES
• Bachelor’s degree, required; preferably in engineering and/or a scientific discipline
• 4-5 years of design quality engineering experience
• Catheter experience or class 3 delivery preferred
• Experience in design transfer – DBT (testing of finished devices)
• Process/equipment investigations
• CAPA experience
• Manufacturing, or research and development experience in medical devices
• Ability to define problems, collect and analyze data, establish f
• Ability to develop and implement Quality standards
• Demonstrated auditing and problem-solving skills
• Knowledge of leading-edge Quality Engineering, design control, and (V&V)
• Ability to effectively collaborate and communicate with internal and external parties
• Theoretical and practical fundamentals such as DOE, DMAIC and ANOVA
• Knowledge of SolidWorks and CAD-based programs
• Six Sigma/ Design for Six Sigma experience, and/or knowledge of Process Excell
• Knowledge of Quality and operations systems and processes, including GMP
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 sponsorship
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