Document Control Specialist

Kelly; Blue Ash (OH); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Medical, Dental, 401K

Paid time off

Annual performance reviews

Kelly benefits

Job summary

Kelly Services in Blue Ash, OH is seeking a Document Control Specialist to support medical device design control and quality documentation activities. This role focuses on managing design control documentation, processing document change requests, and ensuring compliance with QMS requirements.

The ideal candidate has experience in regulated environments, knowledge of FDA regulations and ISO standards, and strong attention to detail, organization, and communication skills.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Quality, or a related technical discipline, or equivalent work experience.
• 2 years of experience in document control or quality systems within a regulated industry.
• Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, GDP/GxP.
• Experience processing ECOs, DCRs, and controlled documentation.
• Strong attention to detail and ability to manage multiple priorities.

Responsibilities

• Prepare, review, and complete design control documentation for design reviews.
• Ensure documents meet GxP, FDA, ISO, and QMS requirements.
• Process DCRs and ECOs with proper documentation.
• Maintain controlled documentation with version control and record retention.
• Collaborate with engineering, quality, regulatory, and other teams.

Skills

Attention to detail

Organizational skills

Communication skills

Time management

Regulatory knowledge

FDA 21 CFR 820

ISO 13485

Document control

Education

Bachelor's degree or equivalent

Job description

Description Kelly Services is currently seeking a Document Control Specialist position for one of our top clients working in Blue Ash, OH.

• Kelly Outsourcing Consulting Group KellyOCG, a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a Document Control Specialist for a 12 month contract for one of our Global clients working in Blue Ash, OH. This role is a full-time (40 hours), 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.

Document Control Specialist — Medical Devices (Design Control & Quality Systems)

Job Summary

We are seeking a Document Control Specialist to support design control and quality documentation activities for medical device product development. This role will be responsible for managing design control documentation, processing document change requests, ensuring compliance with quality management system (QMS) requirements, and supporting design reviews. The ideal candidate has experience working in a regulated medical device environment and is knowledgeable in FDA regulations, ISO standards, and document control best practices.

Key Responsibilities

• Support the preparation, review, and completion of design control documentation for timely Design Reviews.
• Ensure documentation complies with GxP, FDA, ISO, and company Quality Management System (QMS) requirements.
• Process Document Control Requests (DCRs), including creating document and part numbers, engineering change orders (ECOs), and other controlled documentation.
• Perform quality reviews of design control documentation to ensure accuracy, completeness, and compliance with established procedures.
• Maintain controlled documentation in accordance with document control policies and quality standards.
• Provide guidance to project teams on document control, design control, and change control processes and procedures.
• Track document approvals, change orders, and project deliverables while providing regular status updates to stakeholders.
• Collaborate with engineering, quality, regulatory, and cross‑functional teams to ensure timely documentation support throughout the product development lifecycle.
• Assist in maintaining document repositories and ensuring proper version control and record retention.

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Quality, or a related technical discipline, or equivalent work experience.
• 2 years of experience in document control, design control, quality systems, or engineering documentation within the medical device, pharmaceutical, or other regulated industry.
• Working knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and Good Documentation Practices (GDP/GxP).
• Experience processing engineering change orders (ECOs), document revisions, and controlled documentation.
• Strong attention to detail with the ability to review documentation for quality and compliance.
• Excellent organizational, communication, and time management skills.
• Ability to manage multiple priorities in a fast‑paced environment.

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.

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.

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, 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.

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.