Document Control Specialist - Medical Device

Document Control Specialist

Position Overview: The role supports the Quality department with document control, records management, and training compliance utilizing eQMS software. Responsibilities include document review, routing, uploading, archiving, and distribution, along with assisting in system validation and audits. The position involves maintaining compliance with quality procedures and ensuring the accuracy and organization of training and records documentation.

Key Responsibilities:

• Ensure adherence to Document Control, Change Control, Training, and Records Management processes.
• Provide guidance on Document Control procedures, including Change Control, to internal teams and external vendors.
• Maintain regulatory documentation such as Design History Files, Device Master Records, and Batch Records for inspection readiness.
• Manage support and enhancement tickets related to eQMS software.
• Review and update documents, training materials, and records in line with change control protocols.
• Serve as a scribe in important meetings, capturing essential information for organizational success.
• Support electronic Quality Management Systems, including record management, training systems, and electronic signatures, in compliance with established quality procedures.
• Assist with user access, role assignments, and permissions within the eQMS, coordinating with IT and Quality teams.
• Ensure eQMS validation, including managing validation and qualification projects.
• Support the configuration or revision of eQMS workflows.
• Assist with managing training matrices, performance metrics, and record retention policies.
  
  

Required Qualifications:

• Bachelor’s Degree or equivalent experience.
• 5-7 years of relevant experience in document control, records management, and quality systems within the medical device industry.
• Strong understanding of data integrity, good documentation practices, and computer system validation.
• Familiarity with regulatory standards such as 21 CFR Part 4, 21 CFR Part 11, 21 CFR Part 210/211, 21 CFR Part 820, ISO 13485:2016, and ISO 14971:2019.
• Excellent attention to detail, organizational skills, and the ability to work independently in a fast-paced environment.
  
  

Preferred Qualifications:

• Certifications in ISO 13485 or ISO 9001, auditing, records management, or project management.
• Experience in technical writing or configuration management.
  
  

Regular schedule is 8 AM to 4 PM (flexible with start/stop times)

Company typically works a hybrid schedule - 2-3 days on-site per week - this role may require more office time

Pro034

Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.

Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.