Document Control Specialist

Document Control Specialist at Extremitycare. About the role As a Document Control Specialist at Extremitycare, you will play a pivotal role in ensuring that all documentation related to our medical devices is meticulously organized and compliant with industry standards. This position is essential for maintaining the integrity of our documentation processes, which directly impacts product quality and regulatory compliance. You will collaborate closely with various departments to streamline documentation workflows and enhance operational efficiency. Your attention to detail and organizational skills will be critical in supporting our mission to provide high-quality healthcare solutions. Key facts Location: Franklin, Wisconsin Engagement: Full-time Salary: Competitive, commensurate with experience Visa: Sponsorship available for qualified candidates What you'll do Manage the creation, revision, and distribution of controlled documents, ensuring compliance with regulatory requirements and internal policies. Implement and maintain document control systems to ensure easy retrieval and tracking of documents throughout their lifecycle. Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, and Engineering, to gather input and ensure accuracy in documentation. Conduct regular audits of documentation processes to identify areas for improvement and ensure adherence to established protocols. Train staff on document control procedures and best practices to foster a culture of compliance and quality. Assist in the preparation of regulatory submissions by ensuring that all necessary documentation is complete and accurate. Monitor and report on document control metrics to management, highlighting trends and areas needing attention. Support the development and maintenance of standard operating procedures (SOPs) related to document control processes. Participate in continuous improvement initiatives to enhance the efficiency and effectiveness of document management systems. Ensure that all records are maintained in accordance with applicable laws and regulations, including FDA and ISO standards. Facilitate the archiving and retrieval of documents to ensure compliance with retention policies. Serve as a point of contact for internal and external audits related to document control practices. Requirements Bachelor's degree in a relevant field, such as Life Sciences, Engineering, or Business Administration. A minimum of 3 years of experience in document control or a related role within a regulated industry, preferably in medical devices or pharmaceuticals. Strong understanding of regulatory requirements, including FDA regulations and ISO standards related to document management. Proficiency in document management software and tools, with experience in electronic document control systems. Excellent organizational skills with a keen attention to detail and accuracy. Strong communication skills, both verbal and written, to effectively collaborate with team members and stakeholders. Nice to have Experience with Lean Six Sigma methodologies or other process improvement frameworks. Familiarity with quality management systems (QMS) and risk management principles. Certification in Document Control or Quality Assurance is a plus. Knowledge of project management principles and practices. Skills & tools Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and document management software. Strong analytical skills to assess document control processes and identify areas for improvement. Ability to work independently and manage multiple priorities in a fast-paced environment. Familiarity with electronic signature and approval workflows. Practical notes This position is based in Franklin, Wisconsin, and may require occasional travel for training or audits. The company offers a competitive salary and benefits package, including health insurance, retirement plans, and opportunities for professional development. Candidates must be eligible to work in the United States, and visa sponsorship is available for qualified individuals. The ideal candidate will be proactive, detail-oriented, and committed to maintaining high standards of quality and compliance in all documentation processes. At Extremitycare, we are dedicated to improving patient outcomes through innovative medical solutions. #J-18808-Ljbffr