Job Description

Position Summary 

The Documentation Specialist plays a critical role in maintaining document integrity and configuration control across our medical device organization. This position manages the complete lifecycle of technical documents and change orders, ensuring compliance with quality standards and regulatory requirements. The role involves close collaboration with Operations, Engineering, and other departments to support both new initiatives and ongoing projects.

Job Responsibilities

Responsibilities include, but are not limited to:

Document Management & Control:

• Maintain comprehensive logs of current and archived documents and records
• Coordinate regularly scheduled document reviews and updates with document owners
• Ensure the accessibility of current quality documents and the prevention of unintended use of any outdated documents
• Safeguard paper and electronic records to ensure confidentiality, integrity, and retrievability
• Manage document retention in accordance with quality procedures and timelines

Change Order Processing:

• Process formal change orders from initiation through final approval in accordance with quality procedures
• Collaborate with requestors and owners to ensure complete, accurate, and correctly cross-referenced documentation
• Verify and document the completion of all post-approval actions before publishing changes

Quality and Compliance: 

• Ensure compliance with applicable laws, regulations, source material copyrights, and acknowledgements, and established company quality and documentation standards
• Actively promote Good Documentation Practices
• Edit documents for clerical accuracy, grammar, and consistent formatting

Support and Training: 

• Identify and escalate document or recordkeeping issues to management
• Deliver documentation training to personnel across multiple departments

Required Qualifications:

• High School diploma or equivalent
• 3+ years of work-related experience in a regulated industry (e.g., pharmaceutical, medical device, automotive, aerospace)
• Fluency in English, with excellent verbal and written communication skills
• Knowledge of product configuration management structures, bills of material, and tools
• Experience working with electronic quality management systems (eQMS) to create, revise, retain, and obsolete documents and records
• Ability to read and accurately interpret requirements and notes on drawings and specifications
• Ability to collaborate with and provide training to a variety of team members and departments
• Attention to detail and accuracy
• Understanding of regulatory compliance principles

Preferred Qualifications:

• Associate’s (or higher) degree
• Previous medical device experience
• Familiarity with desktop publishing software (Adobe, Microsoft, etc.)
• Quality management system certification (e.g., ISO 13485, IATF 16949, AS9100)
• Experience with change control processes
• Training or presentation experience
• Experience with technical drawing interpretation

Physical Requirements: 

• The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to be independently mobile. The employee

Benefits:

• 401(k) with company match
• Dental Insurance
• Health Insurance
• Vision Insurance
• Life Insurance
• Paid Vacation

Work Location: OnSite

Schedule: Monday-Friday; day shift

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