The posting
AirStrip is seeking an experienced Document Control Specialist with organizational, communication, and problem-solving skills, including a sharp attention to detail and a results-oriented mindset. The role supports compliance with SaMD documentation requirements, including traceability across design, development, verification, validation, and release phases, ensuring regulatory and audit readiness under MDSAP and international frameworks.
The position has a preference for candidates in the San Antonio, TX market, and requires up to 10% travel to company office locations.
Responsibilities include, but are not limited to:
Maintain and administer the document control process in accordance with ISO 13485:2016 Section 4.2.4 and 21 CFR 820.35. Manage document lifecycle activities including creation, revision, approval, distribution, and obsolescence. Ensure controlled access to QMS documents, procedures, work instructions, and records. Oversee the use of the eDMS for all controlled documents, forms, templates, and training records. Coordinate document reviews and approvals with cross-functional teams including Software Engineering, Product (DPMO), and Clinical Affairs. Ensure version control and traceability for all QMS and product documentation (e.g., DHF, TF, DMR, DHR). Support internal and external audits, providing controlled documentation and traceability evidence. Train employees on document control procedures and ensure compliance with established processes. Issue and facilitate training programs for Employees and Contractors, while maintaining and updating the LMS effectively. Oversee and manage QA/RA Department budgeting activities. Manage and coordinate Corrective and Preventive Action (CAPA) processes. Support change control and record retention per regulatory and company policy requirements.
Education & Experience Requirements
Associate's degree in Quality Assurance, Regulatory Affairs, Engineering, or related field (commensurate experience will be considered in lieu of degree) Minimum 2 years of experience Document Control experience in a medical device or SaMD environment Minimum 2 years of experience ISO 13485, 21 CFR 820, MDR, MDSAP documentation requirements Minimum 1 year experience Experience with eQMS or eDMS platforms
Required Knowledge, Skills, and Abilities:
Strong organizational, planning, and follow-up skills Strong interpersonal communication (written and verbal) Effective problem-solving skills; results-oriented Outstanding attention to details Creative and innovative thinker Coaching and mentoring for direct reports Familiarity with Quality Management System (QMS) and their application in SaMD. Experience conducting audits and ensuring compliance with SOPs and industry standards Understanding of regulatory standards (21 CFR 820, ISO 13485, EU MDR, MDSAP). Proficiency in eQMS/eDMS software. Ability to oversee document control processes, including the creation, review, approval, distribution, and archival of documents.
The hourly range for applicable San Antonio-based applicants to this position is below. The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location.
$29.64/per hour - $35.63/per hour, plus bonus potential



