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1+ months

Quality Engineer (medical devices)

Kelly Services
Deerfield, IL 60015
Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting 6+ month, long term contract opportunity as a Quality Engineer for a top fortune 500 company in Deerfield IL.





**Title:** Quality Engineer II, New Product Development (NPD) and Sustaining Product



**Duration:** 6+ month



**Location:** Deerfield IL





**Essential Duties and Responsibilities:**




+ Bio-surgical Medical device sustaining related project to ensure we address the business needs in a cost effective and complaint manner.

+ Engineer will be responsible for sustaining the products in the field in compliance with the quality system and technical expertise.

+ Hands on experience with product development and Processing of change controls, designing, developing, implementing and evaluating optimal, cost-effective projects and technologies.

+ Must have experience or advanced training and demonstrate proficiency in change controls, Investigations, problem solving, statistical methods, DHF remediation, Risk file remediation, problem analysis and resolution, materials science, design of experiments etc.

+ Good understanding of remediation; extensive cross-functional team experience, including technical and non-technical work.

+ Completely proficient in relevant products development processes in compliance with FDA design control 21CFR820.3 and ISO13485

+ Understanding 21CFR600 is also preferred

+ Act independently with minimal supervision to conduct smaller approved projects. Expected to make suggestion on improvements based on recent technical knowledge.

+ Contribute to the planning and execution of components of the development process, which apply to product revision or enhancement or a defined piece of a larger project.

+ Ability to manage routine small projects without assistance.

+ Investigate and analyze customer service problems and design improvement suggestions. Recommend design improvements

+ Strive to be compliant and have Big picture understanding





**Qualifications:**




+ Knowledge of the basic principles in various engineering disciplines.

+ Must have initial training in concepts of: Six Sigma & Quality techniques

+ Must know how to coordinate with cross functional team and open to learning quickly and aligning on big picture

+ Design Control Elements

+ Risk Management Elements

+ Software: Trackwise8 proficiency, Word, Excel, Visio, PowerPoint, Outlook

+ Change Control TW8 system experience

+ Good communication skills - written and spoken

+ Product development focus: Medical Surgical Tools: implantable, Bio surgical device and Biologics.

+ Emphasis more on DHF remediation, Risk File remediation/creation and processing of change controls.

+ 3-5+ years of recent and relevant product development experience in medical device industry experience (Pharma is not transferable). Medical Device Class II & III experience.

+ BS in Engineering (discipline: Biomedical, Mechanical preferred)

+ Software: Trackwise8 proficiency, Word, Excel, Visio, PowerPoint, & Outlook





**Education / Experience:**




+ BS in Engineering (discipline: Mechanical, Biomedical preferred)

+ 3-5+ years of recent and relevant product development experience





**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. Please contact Michelle Niemira ( micn083@kellyservices.com ) for immediate consideration.





**Why Kelly?**




+ As a Kelly Services employee, you will have access to numerous perks, including:

+ Exposure to a variety of career opportunities as a result of our expansive network of client companies

+ A competitive hourly pay rate with weekly checks

+ Access to newly expanded Medical Plan options

+ Online continuing education via the Kelly Learning Center

+ Several employee discounts

+ And more!




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



As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.




**About Kelly** ****



At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

\#KellyGTS
Posted: 2020-10-26 Expires: 2020-12-26

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Quality Engineer (medical devices)

Kelly Services
Deerfield, IL 60015

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