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.