Job Details

Position: Document Control Specialist 3

Client: Leading Medical Device Manufacturer

Duration: 1 - Year Contract (Possible to Extend)

Pay rate: $ 48.00 /hr on W2

Location: Chapel Hill, North Carolina 27517

Shift: 8.00 am to 5.00 pm – (Monday to Friday)

1. Bachelor’s Degree in Engineering or a Technical Field
   Solid educational foundation in engineering or a related technical discipline.

2. Experience in Medical Device or Regulated Industries
   At least 3 years of experience in an ISO 9001 or regulated product development environment, especially medical devices.

3. Strong Understanding of Design Control Documentation
   Skilled in compiling and maintaining Design History Files (DHFs) including specifications, risk analyses, test protocols, and trace reports.

4. Hands-on Experience with Requirements Management Tools
   Proficient in tools like Siemens Polarion, Integrity, or similar platforms for managing design control documents and creating traceability.

5. Proficiency in Lifecycle Management Systems
   Familiarity with Agile PLM or comparable tools to structure DHFs and manage Engineering Change Orders (ECOs).

6. Excellent Technical Writing and Documentation Skills
   Capable of writing, reviewing, and editing technical documents such as requirements, risk analyses, and test protocols with clarity and precision.

7. Detail-Oriented and Quality-Focused
   High attention to detail and dedication to producing consistent, high-quality documents that meet regulatory standards.

8. Collaborative Team Player
   Able to work closely and effectively with engineering, quality, and technical publication teams.

9. Experience in Risk Management (FMEA)
   Involvement in Failure Modes and Effects Analysis (FMEA) and other risk documentation practices.

10. Comfortable with Complex Technical Content
    Ability to understand and communicate complex systems, especially those combining hardware and software components.

11. Strong Organizational and Planning Skills
    Ability to coordinate multiple tasks and documentation efforts across various phases of product development.

12. Proactive and Process-Oriented
    Passionate about process improvement, continuously looking for ways to enhance documentation structure and traceability.

13. Strong Communication and Interpersonal Skills
    Capable of articulating document control needs and collaborating with cross-functional teams.

14. Experience Aligning Documentation with Regulatory Standards
    Familiar with aligning manuals, IFUs, labels, and training materials with FDA/ISO requirements.

15. Proficiency in Core Software Tools
    Skilled in Microsoft Word, Excel, and Adobe Acrobat for document preparation and management.