QMS and Document Control Specialist - HOLT Manufacturing

About the role

The QMS & Document Control Specialist is responsible for maintaining, improving, and controlling the organization’s Quality Management System (QMS) and all controlled documentation. This role ensures compliance with applicable standards, regulatory requirements, and internal procedures by managing document lifecycle activities, supporting audits, and promoting consistent quality practices across the organization.

Responsibilities

• Models, promotes, reinforces, and rewards the consistent use of HOLT’s Values Based Leadership (VBL) tools, models, and processes to ensure alignment with our Vision, Values, and Mission
• Authors/facilitates, revises, and controls SOPs, ECNs, Work Instructions, job aids, forms, and quality records in alignment with ISO 9001 and internal QMS requirements
• Owes the full document control workflow, including numbering, revision control, approvals, obsolescence, distribution, and accessibility
• Owes the Engineering Change Notice process, facilitates the implementation of the ECN working with all Operational and Support teams to ensure a smooth transition of engineering changes
• Ensures all controlled documents reflect the current approved process and are maintained in an audit ready state
• Collaborates with management and the Quality department to maintain a compliant and continually improving QMS documentation structure
• Leads preparation activities for internal and external ISO 9001 audits, ensuring documentation accuracy, completeness, and conformance to QMS standards
• Supports and participates in internal audits, including scheduling, planning, execution, documentation review, evidence collection, and follow up verification
• Coordinates with the Quality Manager to support external ISO 9001 audits, including certification, surveillance, and supplier and customer audits
• Pairs with process owners to correct documentation gaps identified during audits, ensuring timely implementation of corrective and preventive actions
• Maintains the internal audit system by tracking findings, managing corrective actions, and confirming closure and effectiveness
• Works safely at all times and adheres to all applicable safety policies; complies with all company policies, procedures, and standards

Requirements

• Regular and punctual employee attendance
• Perform other duties as assigned

Knowledge, Skills, And Abilities

• Strong understanding of ISO 9001:2015 audit requirements, audit process flows, and preparation best practices
• Experience performing or supporting internal audits and responding to findings from external regulatory or customer audits
• Ability to guide departments in preparing documentation and objective evidence for both internal and external audits
• Document control and data management Process discipline and compliance mindset
• Problem-solving and analytical thinking
• Cross-functional collaboration
• Continuous improvement orientation
• Proficiency in Microsoft Office and document management software

Education and Experience

• Associate’s or Bachelor’s degree in Quality, Engineering, Manufacturing, Business, or a related field (or equivalent experience)
• 2–5 years of experience in Quality Systems, Document Control, or a regulated manufacturing environment required
• Working knowledge of QMS standards (ISO, IATF, FDA, or similar)
• Experience with document control systems or electronic QMS tools
• Strong attention to detail and organizational skills
• Ability to manage multiple priorities and deadlines
• Strong written and verbal communication skills

Supervisory Responsibilities

None

Travel

Up to 25%

Physical Requirements

• Frequent movement and use of limbs
• Good manual dexterity, coordination, and stamina
• Routinely reacts to visual, auditory, and other signals, including alarms and instructions
• Visually inspects work
• Occasionally moves materials or equipment weighing up to 20 lbs.

Work Environment

This job is generally performed in a professional office environment, in environmentally controlled conditions. Frequently works at a fast pace with unscheduled interruptions.

Disclaimer

Please note that the above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not to be interpreted as an exhaustive list of all responsibilities, duties, and skills required of incumbents so classified. All incumbents may be required to perform duties outside of their normal responsibilities, as needed.