Job Description

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 Developmen

t
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 testin

g.
Key Responsibiliti

es:• 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 lifecyc

le.• Leading efforts for continuous quality and customer satisfaction improvement opportuniti

es.• 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 PFM

EA.• Write, review and/or approve process and product validation protocols and reports, equipment qualifications, and engineering change orde

rs.• Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, Statistical Process Control (S

P C)• Design of Experiments (DO E), e

tc.• 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 specificatio

ns.• Technical problem-solving, failure analysis, and root cause determinati

on.• Makes decisions independently on engineering problems and methods and represents the organization in conferences to resolve important questions and to plan and coordinate wo

rk.• Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipme

nt.• Assigns/reviews quality inspection testing and test da

ta.• Keeps department supervisor abreast of activities and issues of the quality gro

up.• Responsible for ensuring personal and Company complia

nce• Performs other duties assigned as nee

ded
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICE

NS ES• Bachelor’s degree, required; preferably in engineering and/or scientific discip

line• 4-5 years of design quality engineering experie

nce.• Catheter experience or class 3 delivery prefe

rred• Experience in design transfer – DBT (testing of finished devi

ces)• Process/equipment investigat

ions• CAPA experi ence a

plus• Manufacturing, or research and development experience in medical dev

ices• Ability to define problems, collect and analyze data, establish f

acts• Ability to develop and implement Quality stand

ards• Demonstrated auditing and problem-solving sk

ills• Knowledge of leading-edge Quality Engineering, design control, and (V&V) t

ools• Ability to effectively collaborate and communicate with internal and external part

ners• Theoretical and practical fundamentals such as DOE, DMAIC and ANOVA is a p

lus.• Knowledge of SolidWorks, and CAD-based prog

rams• Six Sigma/ Design for Six Sigma experience, and/or knowledge of Process Excell

ence• Knowledge of Quality and operations systems and processes, including GMP is a p

lus.
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 spo

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