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1+ months

Medical Device NPD Quality Engineer

Kelly Services
Irvine, CA 92604
_Kelly Engineering, Outsourcing & Consulting Group (KellyOCG), a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a_ **_Medical Device NPD Quality Engineer_** _for a long-term (2 year) engagement_ **_with high a probability of going full time with_** _one of our global clients, a leader in the science of diagnosing and treating heart rhythm disorders, located in_ **_Irvine, CA._**


_This role is a full-time, fully benefitted position. As a KellyOCG employee you will be eligible for_ **_50% paid Medical, Dental, 401K_** _and a variety of other benefits to choose from. Youll also be eligible for paid time off, including_ **_holiday, vacation and sick/personal time_** _._


_All KellyOCG employees receive annual performance reviews._


**_Contract and a highly possible full time direct hire_** **_opportunity_** **_!_**


_The_ **_NPD 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 companys 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._


**_SECTION 2: DUTIES & RESPONSIBLITIES*_**


_Under limited supervision and general direction and in accordance with all applicable federal, state and local laws/regulations and procedures and guidelines, this position:_


+ _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 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._

+ _Recommend issue resolution to management for significant capability and compliance issues._

+ _Works closely with functional leadership in planning and executing project milestones._

+ _Plans, develops, coordinates, and directs one or more large important engineering projects or a number of small projects with many complex features._

+ _Carries out complex or novel assignments requiring the development of new or improved techniques or procedures._

+ _Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment, when necessary, data are insufficient or confirmation by testing is advisable._

+ _Responsible for communicating business related issues or opportunities to next management levels._

+ _Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures_

+ _Performs other duties assigned as needed._


**_SECTION 3: EXPERIENCE AND EDUCATION*_**


+ _Bachelors degree, required; preferably in engineering and/or scientific discipline_

+ _A minimum of 4 years of quality, manufacturing and or research and development experience in a medical device or other regulated industry_


**_SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS_** _*_


+ _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._


**_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. (_ **_F1 OPT/H1B_** _cannot be considered for this position)._


**Why Kelly** **** **?**


The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ) is one focus within the full array of Kelly Services workforce solutions.


Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.


The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.


**AboutKelly Services** ****


As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook (https://www.facebook.com/kellyservices) , LinkedIn (http://www.linkedin.com/company/kellyservices) and Twitter (https://twitter.com/kellyservices) .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-05-04 Expires: 2022-08-18

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Medical Device NPD Quality Engineer

Kelly Services
Irvine, CA 92604

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