Document Control and ISO Coordinator

* Maintain and administer the facility Quality Management System in accordance with ISO 9001 requirements.
* Support ongoing compliance with internal, customer, and regulatory quality requirements.
* Assist with preparation for external audits, surveillance audits, and recertification audits.
* Monitor quality system effectiveness and identify opportunities for continuous improvement.
* Maintain quality records and ensure retention requirements are met.
* Maintain document control processes for Standard Operating Procedures (SOPs), Standard Work Instructions (SWIs), forms, policies, procedures, and quality records.
* Review document revisions for accuracy, formatting, approval status, and compliance with document control requirements.
* Manage document issuance, revision history, distribution, retention, and archival processes.
* Coordinate document change requests and maintain document control databases and repositories.
* Support new employee orientation related to quality systems and document control processes.
* Coordinate communication of document revisions and quality system updates.
* Promote employee awareness of quality standards, procedures, and best practices.
* High school diploma or GED required with 3 years of relevant experience or AA degree + 1 year of relevant experience
* Experience in Lead auditing and demonstrated experience interfacing with quality systems is preferred.
* Minimum of 3 years of experience in document control, quality systems, manufacturing administration, or a related field; OR Associate degree with 1 year of relevant experience.
* Experience working within a manufacturing environment.
* Strong organizational skills with the ability to manage multiple priorities and deadlines.
* Proficiency in Microsoft Office applications including Excel, Word, PowerPoint, and Outlook.
* Strong written and verbal communication skills.
* Ability to work independently while collaborating effectively with cross-functional teams.
* High attention to detail and commitment to accuracy.
* Self-motivated with the ability to follow through on assignments with minimal supervision.
* Ability and willingness to work occasional overtime as business needs require.
* Demonstrated commitment to safety, quality, and company policies.

* Working Hours:

** Monday through Thursday, four 10-hour shifts (4x10 schedule), starting at 6:00 AM.
*** ISO 9001 Internal Auditor or Lead Auditor certification.
* 5+ years of experience supporting an ISO 9001 Quality Management System in a manufacturing environment.
* Experience supporting an ISO 9001-certified Quality Management System.
* Experience coordinating internal audits or quality system assessments.
* Familiarity with corrective action, root cause analysis, and continuous improvement methodologies.
* Experience working with electronic document management systems.
* Knowledge of quality documentation practices including controlled documents, forms, records, and retention requirements.
* Manufacturing, quality, engineering, or technical administrative experience.
* Proven experience managing a site-wide document control system.
* Strong understanding of ISO 9001 clauses, auditing practices, and quality system requirements.
* Experience leading internal audits and coordinating successful external certification audits.
* Demonstrated success driving closure of corrective actions and sustaining audit readiness.
* Knowledge of Lean Manufacturing, Continuous Improvement, or Six Sigma methodologies.
* Advanced proficiency in Microsoft Excel, including data analysis, reporting, and dashboard creation.
* Advanced proficiency in Microsoft Excel, including data analysis, reporting, and dashboard creation.
* Ability to influence and build effective relationships across all levels of the…