Your Job
What You Will Do
- Administer and maintain the Quality Management System (QMS) document control process.
- Create, format, revise, release, distribute, and archive controlled documents.
- Ensure all documents comply with established formatting and document control requirements.
- Maintain document revision history and traceability.
- Control the issuance and withdrawal of obsolete documents.
- Maintain updated master document and record lists.
- Ensure approved documents are available at points of use throughout the facility
- Process Engineering Change Requests (ECRs), Engineering Change Orders (ECOs), and Document Change Requests (DCRs).
- Coordinate document review and approval workflows.
- Ensure timely implementation and communication of document changes.
- Track document revisions and maintain audit trails.
- Support the maintenance of procedures, work instructions, forms, specifications, and quality records.
- Assist in preparing documentation for internal, customer, and certification audits.
- Provide evidence and records requested during audits.
- Support compliance with ISO 9001 and other applicable quality standards.
- Maintain electronic and hard-copy quality records.
- Ensure proper retention, storage, protection, and disposal of records according to company requirements.
- Facilitate record retrieval for audits, customer requests, and operational needs.
- Monitor record retention schedules and document expiration dates
Who You Are (Basic Qualifications)
- Minimum of 2 years of experience in document control, quality systems, or records management within a regulated manufacturing environment.
- Experience working in organizations regulated by FDA 21 CFR Part 820, ISO 13485, and/or AS9100.
- Experience managing controlled documentation using an Electronic Document Management System.
- Experience supporting internal and external audits.
- Experience with Engineering Change Orders (ECOs), Document Change Orders (DCOs), and change management processes preferred.
- Knowledge of Good Documentation Practices (GDP).
- Proficiency in Microsoft Office Suite (Word, Excel, Outlook, and PowerPoint).
- Exceptional attention to detail.
- Excellent written and verbal communication skills.
- Strong organizational and time management skills.
- Fluency in English.
What Will Put You Ahead
- Experience in high-volume manufacturing environments
- Knowledge of production planning and scheduling systems
- Experience leading continuous improvement initiatives
- Strong communication and cross-functional collaboration skills
Our Team
You will be part of a production team focused on operational excellence, collaboration, and continuous improvement, working closely with cross-functional partners to deliver high-quality results.
At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.
Who We Are
At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.
Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.