30 days old

Staff Quality Engineer

Kelly Services
Irvine, CA 92604
_Kelly Engineering has provided outstanding employment opportunities to the most talented individuals in the marketplace. Today, we are proud to offer a 2-year contract opportunity with_ **_full-time employment highly possible_** _for_ **_4_** **_Quality Engineers_** _._ _Our client, a leader in the_ **_Medical Device industry_** _and is located in_ **_Irvine, CA_**

_This role is a_ **_full-time, fully benefited contract position_** _. As a KellyOCG Engineering employee, you will be eligible for_ **_50% paid_** **_Medical, Dental and 401K and a variety of other benefits to choose from_** _. You will also be eligible for paid_ **_PTO_** _,_ **_time off, including_** **_holiday, vacation, and sick/personal time._**

_All KellyOCG Engineering employees receive annual performance reviews._

The Staff Quality Engineer Leads, plans, supervises, and coordinates 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 leading a team of Quality Engineers and 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.


Under limited supervision and general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, 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.

+ Leading efforts with quality improvement opportunities as appropriate to legacy products,?continuous improvement and customer satisfaction.

+ Oversight, from a Quality NPD perspective, of the Non-Conformance Report (NCR)?process for BWI 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.

+ Support sterility, biocompatibility and packaging test requirements following company standard operation procedures for new products.

+ 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 that subordinates follow all?Company guidelines related to Health, Safety and Environmental practices and that all?resources needed to do so are available and in good condition, if applicable

+ Responsible for ensuring personal and Company compliance with all Federal, State, local and?Company regulations, policies, and procedures

+ Performs other duties assigned as needed


+ Bachelors degree, required; preferably in engineering and/or scientific discipline

+ Masters degree is preferred

+ A minimum of 6 years of quality, 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 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.

+ Ability to lead and mentor a diverse array of employees at all levels of the organization

+ Understanding of theoretical and practical fundamentals and experimental engineering techniques such as DOE, DMAIC and ANOVA.

+ Prior people leadership/management skills.

+ 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 (ie. 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 ATM-14.5Y.

**_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 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 and connect with us on Facebook ( , LinkedIn ( and Twitter ( .

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. (


Posted: 2022-07-15 Expires: 2022-08-15

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Staff Quality Engineer

Kelly Services
Irvine, CA 92604

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