Document Control Specialist (Temporary with Immediate Start)

Document Control Specialist – Temporary (Maternity Leave Coverage) Company: USGI Medical, Inc. Location: San Clemente, CA (On-Site) Employment Type: Temporary, Part-Time (20-30 hours per week) Hourly Rate: $30.00–$39.00 per hour, DOE Start Date: Immediate / As Soon As Possible Anticipated Assignment Duration: Through March/April 2027 IMPORTANT LOCATION REQUIREMENT – PLEASE READ BEFORE APPLYING Applicants must currently reside in Orange County, California to be considered for this position. This is a local hire opportunity. Relocation assistance is not available, and candidates who would need to relocate to Orange County are not eligible for consideration. Please apply only if you currently live in Orange County, California, and meet the qualifications outlined below. About USGI Medical USGI Medical develops innovative endoluminal technologies that enable incisionless procedures, helping patients recover faster and return to their daily activities sooner compared to traditional laparoscopic or open surgery. Our mission is to advance minimally invasive treatment options that improve patient outcomes, reduce recovery times, and help lower overall healthcare costs. About the Opportunity USGI Medical is seeking a detail-oriented, organized, and dependable Document Control Specialist to join our team in a temporary, part-time capacity to provide maternity leave coverage. We are looking for someone who can start as soon as possible to allow for comprehensive onboarding, hands-on training, and knowledge transfer with our current Document Control Specialist before her anticipated leave begins on November 1, 2026. During the initial training period, the selected candidate will work closely with our current specialist to become familiar with our quality management system, document control procedures, and daily responsibilities. Following this transition, the individual will independently manage day-to-day document control activities, ensuring continuity, accuracy, and compliance throughout the leave period. This assignment is anticipated to continue through March 2027, depending on business needs and the employee's return date. The ideal candidate will have previous document control experience, preferably within the medical device industry or another regulated environment, and be comfortable quickly learning established systems and processes. Key Responsibilities Maintain, organize, and update controlled documents, including standard operating procedures (SOPs), work instructions, forms, and quality records. Process Document Change Notices (DCNs), including coordinating document revisions, routing approvals, and ensuring proper version control. Maintain accurate and up-to-date documentation within the company's Quality Management System (QMS). Ensure controlled documents are properly reviewed, approved, distributed, and archived in accordance with established procedures. Collaborate with cross-functional departments to coordinate document updates, obtain approvals, and maintain documentation accuracy. Review documentation for completeness, consistency, formatting, and compliance with internal procedures and applicable regulatory requirements. Maintain document and record repositories, ensuring proper organization, traceability, accessibility, and retention. Support internal and external audits by retrieving, organizing, and preparing requested documentation and quality records. Assist in maintaining and improving document templates, tracking systems, and document control workflows. Identify documentation discrepancies and support continuous improvement initiatives related to document control processes. Light administrative duties from time to time. Qualifications Previous experience in document control, quality documentation, or records management; experience in the medical device industry or another regulated environment strongly preferred. Familiarity with Quality Management Systems (QMS) and document change control processes. Knowledge of FDA quality system requirements and ISO 13485 standards is highly desirable. Experience processing document changes, maintaining revision histories, and managing controlled documentation. Strong attention to detail, with the ability to review documents for accuracy, completeness, and consistency. Excellent organizational and time management skills, with the ability to manage multiple priorities and meet deadlines. Strong written and verbal communication skills and the ability to collaborate effectively with cross-functional teams. Proficiency in Microsoft Office applications and PDF editing tools; experience with electronic document management systems is a plus. Ability to work independently, follow established procedures, and maintain confidentiality of company information. Education Associate's or Bachelor's degree in a related field preferred, or an equivalent combination of education and relevant experience. Join Our Team This is a great opportunity for an experienced Document Control Specialist looking for a flexible, part-time assignment within the medical device industry. You'll play an important role in maintaining the integrity of our quality documentation and supporting the continued efficiency of our operations. #J-18808-Ljbffr