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 Partners 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 time and adheres to all applicable safety policies; complies with all company policies, procedures, and standards Requires regular and punctual employee attendance Performs 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

Requirements 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% Valid driver's license required

Physical Requirements:

Reasonable accommodations may be made to enable individuals with disabilities to perform job duties and responsibilities This position involves extended periods in a stationary position. This role frequently communicates with others, must be able to exchange accurate information in these situations. Constant movement and use of limbs; this position requires good manual dexterity, coordination, and stamina. Routinely reacts to visual, auditory, and other signals, including alarms and instructions, and is required to visually inspect 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 the incumbents so classified. All incumbents may be required to perform duties outside of their normal responsibilities, as needed. 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QMS and Document Control Specialist - HOLT Manufacturing