We are seeking a Quality Management System (QMS) Document Administrator to support a major project in Oneonta focused on changes to the documentation system and preparation for an upcoming audit. This position plays a critical role in the administration of quality management system documents and records, ensuring compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards. The ideal candidate will have strong organizational skills and experience in document control and quality management systems in a manufacturing environment.

Key Responsibilities:

• Document Generation & Maintenance: Generate, review, and maintain quality system documents, including procedures, work instructions, job aids, certificates of conformity, and more, in compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.
• Change Control: Initiate Change Controls and Document Change Requests to update procedures, processes, and documentation to meet evolving requirements.
• Cross-Department Collaboration: Work closely with various departments to update processes and procedures, ensuring all documentation is accurate and aligned with company standards.
• Document Review & Retention: Assist in managing the document review process and ensuring the proper retention of quality documents in accordance with compliance standards.
• Continuous Improvement: Support or lead continuous improvement initiatives for document control-related processes to enhance efficiency and effectiveness.
• Support Quality Assurance Functions: Assist with other Quality Assurance functions, such as internal audits and Corrective and Preventive Actions (CAPAs), as needed.
• Audit Preparation: Help prepare for audits by ensuring that all quality documentation is properly organized and accessible for review.

Minimum Qualifications:

• Education: Associate's or Bachelor’s degree required; a minimum of 2 years of relevant work experience (preferably in a manufacturing environment).
• Skills/Experience:
• Experience with ETQ or other Document Management software is highly preferred.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint, etc.).
• Knowledge of ISO 9001 or other Quality System standards is essential.
• ISO 13485 and 21 CFR 820 Quality Management Systems knowledge is highly preferred.
• Strong attention to detail and accuracy in the execution of work.
• Ability to work independently and collaborate effectively within a team.

Desired Qualities:

• Extremely organized with the ability to handle and compare documentation from multiple resources.
• Detail-oriented with a focus on compliance and maintaining accuracy across all documentation.
• Ability to manage multiple tasks and meet deadlines in a fast-paced environment.

If you are looking for an opportunity to apply your document control and quality management experience while supporting an important project, we encourage you to apply!

To apply, please submit your resume