Job Information
Kelly Services Sr. Quality Engineer (Medical Device Environment) in Cleveland, Ohio
Sr. Quality Engineer (Medical Device Environment)
Location : Solon, Ohio (44139)
Duration : Until 2/2026 (contract extension expectation)
Pay: Negotiable on direct related experience.
W2 Contract - NO CORP TO CORP (C2C) OR THIRD-PARTY RECRUITMENT
Position Summary :
In this role you will support quality system and engineering activities. This includes creating and updating quality system procedures; developing and implementing quality and manufacturing standards and equipment for processing raw materials and/or components for repaired, refurbished, or returned products. This role is essential in enabling the Service Depot to effectively diagnose, repair, or refurbish medical devices or their components. Additionally, this role drives improvements, enhancing Quality, Cost, Speed of repair processes with implementation of lean manufacturing principles in Service business.
Essential duties and responsibilities:
Responsible for overall service quality management of the site.
Responsible for the quality system of the site including maintaining compliance to regulatory requirements and certifications (ISO 13485) and supporting audits.
Initiate and complete change cycle for updated QMS documents including change implementation and training.
Engage and interface in internal and external audits providing subject matter expertise.
Act as internal Auditor of company QMS
Support day to day service operations and addressing line requests by acting as Subject Matter Expert for Quality and Manufacturing standards.
Support the creation and maintenance of service procedures for incoming analysis, trouble shooting, repair, and inspection of products returned from customer.
Own, maintain and improve Service line(s) layout, setup, configuration, and fixturing.
Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
Support continuous improvement initiatives with suppliers and in-house teams to improve Quality, reduce cost, and increase efficiency and effectiveness of Service processes.
Collaborates with cross functional teams and suppliers to address quality issues and align practices.
Own internal and supplier non-conformances and manage the timely disposition and closure of NCRs/NCs
Required Experience
5 + years of engineering experience in medical device environment.
Must have experience creating and updating quality management system (QMS) documents.
Must have knowledge of applicable domestic and international regulations and quality system standards – FDA QSR, MDD, ISO3485, ISO9001, etc.
Ability to work independently from discovery to implementation.
Ability to work with remote teams as needed.
Excellent communication skills, time management and organization sills with attention to detail.
Previous experience in a regulated environment and understanding of Medical Device manufacturing processes is desirable.
Important information : To be immediately considered, please send an updated version of your resume to Deas172@kellyservices.com .
* (Kelly does not expense relocation/interview costs)
Work Authorization: Must be able to work in the United States with current employment authorization documents.
In addition to working with the world’s most recognized and trusted name in staffing, Kelly employees can expect:
Competitive pay
Paid holidays
Year-end bonus program
Recognition and incentive programs
Access to continuing education via the Kelly Learning Center
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Engineering?
Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we’re here to guide you to the next step in your engineering career.
About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
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