Document Control Specialist - Medical Devices & Design Control

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

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.