Document Control Clerk

Paragon Medical, a business of AMETEK, is a trusted partner in medical device manufacturing, offering end-to-end solutions from concept to final production. With expertise across various applications, we deliver high-precision components and complete products tailored to exceed customer expectations. Job Summary Responsible for the document control system and functions for individual site facility. Duties and Responsibilities Assist the Quality Manager in the continuous improvement, trending, and tracking of the Quality Management System, including the following: CAPA System

• Monitor for timely closure and effectiveness. Complaince System
• reporting, trending, and tracking. Monitor the Internal Audit program and trend and track data. Participate in Quality Management System Reviews. Participate in 3rd party inspection
• FDA, Notified Bodies, and Corporate.

Conduct quality system training of personnel in Quality Control and Quality Assurance procedures. Ensure all Quality Management System documents are properly controlled, maintained, and protected. Continuous analysis and improvement of document control protocols, systems, and processes, ensuring both internal and external regulatory requirements are met. Maintain an in-depth working knowledge of ISO and FDA requirements. Responsible for reconciliation and training of document control procedures and practices across functional disciplines. Identify ways to improve and eliminate waste in our transactional procedures. Verify document revision levels. Lead cross-functional teams to complete special projects and support continuous improvement of work instructions and operating procedures. Track departmental metrics and assist with establishment of document control performance metrics. Understand, practice, and enforce corporate policies and procedures. Responsible for archiving and retrieving the Quality System Files as required by the Document Management System. Occasional Duties May assist with DMR updates, Work Order packets creation, and other Document Control Clerk activities. Manage direct reports or interns as department needs warrant. Participate in special assignments as requested. Once employee demonstrates competency in position, he/she may be required to train others in similar role. Education High School or GED Experience 3-6 years Knowledge/Skills/Abilities Extensive understanding of blueprints and drawings. Ability to read, interpret, and compare prints. Interpersonal communication and teamwork skills required. Strong organizational skills and ability to ascertain priorities for diversified tasks. Computer skills include proficiencies in MS Office suite, database systems, ERP/MRP software, and electronic document management systems. Ability to work independently with little supervision. Ability to independently solve problems and make recommendations. Ability to handle multiple tasks in a changing environment. Excellent oral, written, and telephone communication skills. Leadership skills and ability to influence others. Skilled in dealing with all levels of staff, production through management. Positive approach and attitude toward work. Strong leadership, interpersonal, and employee development skills. Ability to work and contribute to a team-oriented, continuous improvement, and manufacturing environment. Excellent attention to detail and established procedures required. Excellent follow-up skills required.