Senior QMS & Document Control Specialist

Description

The Senior Quality Management System & Document Control Specialist is responsible for administering and maintaining the company's QMS & Document Control systems to ensure the integrity, accuracy, accessibility, and compliance of controlled documentation throughout its lifecycle. This role serves as the subject matter expert for Quality Management & Document Control processes and supports Quality, Engineering, Manufacturing, Operations, Facilities, and other departments by managing controlled documents, engineering change documentation, quality records, and document workflows.

The Senior QMS & Document Control Specialist ensures compliance with applicable quality management system requirements, customer requirements, regulatory standards, and internal procedures while supporting continuous improvement initiatives.

Essential Responsibilities

• Administer and maintain the company's QMS and Electronic Document Management System (EDMS) and document control processes.
• Create, review, route, publish, revise, archive, and retire controlled documents including:

                    *Standard Operating Procedures (SOPs),

                    *Work Instructions,

                    *Policies,

                    *Forms,

                    *Specifications,

                    *Engineering drawings,

                    *Manufacturing procedures,

                    *Test methods,

                    *Quality manuals.

• Coordinate document review and approval workflows with document owners and functional leadership.
• Maintain document revision history and ensure only current approved versions are available for use.
• Manage Engineering Change Orders (ECOs), Engineering Change Notices (ECNs), and document revisions in accordance with established procedures.
• Ensure timely implementation of engineering and quality document changes throughout the organization.
• Maintain document retention and archival processes in accordance with company policy and regulatory requirements.
• Conduct periodic audits of controlled documentation to ensure accuracy, completeness, and compliance.
• Support internal audits, customer audits, certification audits, and regulatory inspections by providing requested documentation and records.
• Monitor document control metrics and recommend process improvements to increase efficiency and compliance.
• Develop and maintain document control procedures, templates, naming conventions, and document standards.
• Train employees on document control policies, procedures, and document management systems.
• Work closely with Engineering, Manufacturing, Quality, Supply Chain, Facilities, EHS, and Operations to ensure document accuracy and consistency.
• Assist with implementation and continuous improvement of Quality Management System documentation.
• Maintain confidentiality of proprietary, technical, and company-sensitive information.
• Perform other duties as assigned 

 Work Environment

This position is primarily performed in an office environment with frequent interaction with manufacturing, engineering, laboratory, and cleanroom personnel. The position requires regular movement between office and ( 10 % ) cleanroom/production areas to support document control activities, audits, and engineering change implementation

Occasional work outside normal business hours may be required to support production schedules, audits, or business needs.

Physical Demands

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The employee is regularly required to:

• Sit for extended periods while working on a computer
• Use hands and fingers to operate computers and office equipment.
• Communicate effectively verbally and in writing.
• Occasionally stand, walk, bend, reach, and lift or move materials weighing up to 20 pounds.
• Travel throughout office, cleanroom, and production facilities as needed.

Requirements

•  Associate degree in Business Administration, Quality, Engineering Technology, Technical Communications, or a related field; equivalent experience may be considered.
• Minimum of five (5) years of document control experience in a regulated manufacturing environment.
• Minimum of three (3) years supporting Quality Management Systems.
• Experience managing engineering documentation and revision control.
• Experience supporting Engineering Change Orders (ECOs) and document change processes.
• Experience with electronic document management systems (EDMS).
• Proficiency with Microsoft Office applications.

 Preferred Educ