Document Control Specialist 1

Position Summary:

The Document Control Specialist 1 executes and enforces the Document Control processes and systems used to support Cadwell’s industry-leading neuro-diagnostics equipment. The Document Control Specialist organizes, manages, and controls Cadwell’s current and historical documentation repositories in accordance with Company and regulatory requirements. They review and execute Engineering Changes, updates to Cadwell processes, part number requests, and regulatory compliance documentation.  

Job Duties And Responsibilities:

• Manages Cadwell’s documentation in accordance with company and regulatory requirements, ensures accurate and complete version control
• Reviews and processes Engineering Changes (ECs), ensuring changes are clearly documented following standard good documentation practices
• Implements Bills of Materials (BOMs) in Cadwell’s ERP system
• Processes regulatory compliance documentation, ensuring full compliance with 21 CFR Part 11 and company requirements
• Processes part number requests, including creating item records in Cadwell’s ERP system
• Provides support during internal and external audits by providing requested documentation and demonstrating overall accuracy of the document control system
• Ensures document control activities follow written processes in compliance with ISO 13485, company requirements, and other applicable regulatory requirements
• Executes small projects in documentation focused areas
• Performs other duties as assigned

Qualifications: Knowledge, Skills, and Abilities:

• Working knowledge of version control best practices
• Working knowledge of engineering change control processes
• Preferred Working knowledge of good documentation practices (GDP)
• Preferred Working knowledge of Enterprise Resource Planning (ERP) systems and BOMs structures
• Work as part of a cross-functional team with a professional and solutions-oriented approach; ability to manage more than one effort at once
• Strong attention to detail with a high degree of accuracy

Education and Experience:

• Associate’s degree in technical field or equivalent worked experience
• Typically at least one (1) year of relevant document control experience or related work
• Preferred experience working in a regulated environment, ideally in a medical or similar engineering and/or quality focused industry

Physical Requirements And Working Conditions:

• Positions working with Cadwell equipment generally may require some reaching, bending, stooping, squatting, crawling, kneeling, pushing, pulling, lifting and carrying up to 50 pounds (infrequent), finger dexterity, repetitive motions, standing, walking, sitting, hearing, visual acuity, color vision, and 2-way written/verbal communication. More specific details may be provided as needed or requested.
• Extensive use of a computer will be required.
• Travel may be required; must be able to obtain necessary travel documents.
• Work hours outside normal business hours may be required at times to meet business needs.

Cadwell Industries, Inc. is an Equal Opportunity Employer, and as such affirms the right of every person to participate in all aspects of employment without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. If you are interested in applying for employment and need special assistance or an accommodation to apply for a posted position, contact our Human Resources department at [email protected]