Description
Quality Engineer (QE) resource will be allocated to work with the facilities/construction projects, mainly in Collagen Manufacturing areas. The QE resource is required to be part of the Core Team of the facilities projects, participate on meetings and to review and approve all documentation required such as PCDT, Change Control, EMPQ, equipment qualifications, documents changes, RM changes, calibration/PM documents. The existing QE positions are fully working on the day to day activities per Manufacturing Area.
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. Knowledge of qualifying new facility additions - HVAC, water filter systems medical device experience preferred not required.
• BS in Chemical, Biomedical, Mechanical, or Industrial Engineering
• 5 to 7 years minimum experience in an FDA regulated environment.
• ASQ Certified Quality Engineer (CQE) and/or Quality Auditor (CQA) preferred.
• Experience with Quality System Regulation (QSR), ISO, Design Control and Process Validation guidelines.
• Able to develop technical documentation such as: Validation Protocols, Technical / investigation reports, SOP, Validation Plans, Change Controls, and others.
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 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.
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