Quality Validation Engineer

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10201082 Posted today Back Jacksonville, FL, US Engineering Bachelors Degree Full Time, Temporary $45-$50/hr Entry Level On-site Medical Devices and Supplies First Shift (Day) Jacksonville, FL, US $45-$50/hr Entry Level Full Time, Temporary Medical Devices and Supplies On-site Engineering Bachelors Degree First Shift (Day) Apply Now Applied Job details Quality Validation Engineer Kelly Services is currently seeking a Quality Validation Engineer position for one of our top clients in Jacksonville, FL. Kelly Outsourcing Consulting Group KellyOCG, a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a Quality Validation Engineer for a long-term engagement at one of our Global clients in Jacksonville, FL. This role is a full-time, fully benefited position. As a KellyOCG employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. You'll also be eligible for paid time off, including holiday, vacation and sick/personal time. All KellyOCG employees receive annual performance reviews. As a Quality Validation Engineer placed with KellyOCG you will be responsible for the following: The Quality Validation Engineer will lead and support validation and qualification activities for lidstock and heat-seal processes and related raw materials, ensuring compliant execution of

IQ/OQ/PQ

documentation, robust change control, and alignment with the Quality Management System (QMS). Author, review, and execute qualification documentation (IQ/OQ/PQ protocols and reports) for lidstock and heat-seal processes, ensuring traceability to requirements and acceptance criteria. Lead and support implementation, qualification, and validation of new raw materials and process changes for production lines under the direct supervision of Client stakeholders. Support process characterization activities by preparing test strategies, data collection tools, and executed test records; compile, analyze, and summarize results to support qualification conclusions. Manage and support change control activities (change requests/records), including impact assessment, risk assessment (e.g., FMEA), implementation actions, and required documentation updates. Review, maintain, and improve controlled documents (quality procedures, test methods, and specifications) in support of process and product validation. Ensure qualification/validation packages are complete and compliant, including executed protocols, deviation documentation, investigations, final reports, and approvals per the QMS. Provide technical input to investigations, deviations, nonconformances, and CAPAs, including containment/bounding, root cause analysis, action effectiveness, and timely closure. Ensure day-to-day activities align with applicable requirements (FDA 21 CFR 820, ISO 13485, GxP) and support internal/external audits through documentation readiness and response support.

Experience:

Hands-on experience supporting validation deliverables and technical documentation (DOE, IQ/OQ/PQ protocols and reports). Experience submitting test documentation and managing change requests/change control in a regulated quality system. Experience conducting nonconformance investigations, root-cause analysis, and CAPA support. Experience in a regulated industry (medical device preferred) with familiarity with FDA expectations. Working knowledge of statistics and Design of Experiments (DOE), including basic data analysis and interpretation. Six Sigma certification (Green Belt/Black Belt) is a plus. Strong analytical skills, including risk assessment and attention to detail in technical documentation. Ability to work independently, communicate effectively with stakeholders, and manage priorities; project management experience is preferred. Proven ability to work in a cross-functional matrix environment, build strong relationships, and serve as a subject matter expert when needed. Flexible and able to manage multiple priorities; willing to adjust schedule as required by business needs.

Important information:

This position is recruited by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. 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. As a Kelly Services employee, you will have access to numerous perks, including: Vacation and sick pay Paid holidays 401(k) plan Group medical, vision, dental, life, and short-term disability insurance options Kelly Discounts on goods and services, auto and home insurance, and tuition at Kelly partner schools Kelly Learning Center offers free courses and trainings Weekly pay About Kelly 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 , 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. 10201082 Share this job Copied url To save a job sign in or get started To apply for this job email your details to I want more jobs like this in my inbox.

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Share this job Copied url Link Copied Similar Jobs To save a job sign in or get started Engineering Associate Jacksonville, FL, US Full Time, Temporary $45-$50/hr 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. Find what's next with Kelly ® . As a worker today, it's up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what's next is what we're all about. We know what's going on in the evolving world of work—just ask the 440,000 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 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 is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly 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.