Document Control Associate II

Job Summary

The Document Control Associate II is responsible for maintaining and administering quality system documentation and records within the electronic Quality Management System (eQMS). This role ensures controlled documents are reviewed, approved, released, revised, and archived in accordance with established procedures and regulatory requirements. The position supports document change management, records retention, audit readiness, and cross-functional communication with internal stakeholders and customers to ensure the timely and compliant execution of document control activities.

Essential Job Duties and Responsibilities

• Maintain document control records within the electronic Quality Management System (eQMS).
• Ensure controlled documents are reviewed, approved, released, revised and archived in accordance with established procedures.
• Support user access and document workflow activities within the document management system.
• Monitor and track document change activities to ensure timely completion and compliance with established timelines.
• Make suggestions for combining changes, separating changes, and timing of changes pursuant to the activities planned and the resources requirements.
• Attend regular team meetings to stay current with tasks and deliverables.
• Liaison with customer’s primary contact persons for documentation, quality, and regulatory to ensure effective and efficient communication within the defined process for change controls.
• Facilitates changes within defined record management and maintenance requirements of the quality system documentation and records.
• Manage quality records in accordance with record retention procedures and regulatory requirements.
• Provide document control support during internal, customer and regulatory audits.
• Retrieve and provide documentation requested during audits and inspections.

Education and Experience Requirements

• Associate's or Bachelor's degree in Business, Engineering, Science, Quality, or a related discipline preferred.
• Minimum 2 years of document control, quality systems, records management, or administrative experience in a regulated industry.
• Medical device, pharmaceutical, biotechnology, or other regulated industry experience preferred.

Preferred Skills and Abilities

• Excellent written and verbal communication skills in English.
• Knowledge of document control principles and Good Documentation Practices (GDP).
• Experience in documentation control in either medical or other government regulated field preferred, but not required
• Experience with Electronic Data Management Systems, such as Grand Avenue, IFS, or Master Control is a plus.
• Working knowledge of engineering drawings and revision control practices is preferred.
• Organizational and communication skills, attention to detail and the ability to manage multiple priorities.

Working Conditions and Physical Demands

While performing the duties of this job, the employee is regularly required to look at a computer screen, reports and other documents. The employee is regularly required to use their hands on a computer keyboard or a calculator. The employee is regularly required to sit, talk, hear and interact with other employees. The employee is regularly required to stand and walk.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

On-site role in a cleanroom and controlled manufacturing environment.

Equal Opportunity Statement

Quasar Medical provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status, or any other status protected by applicable federal, state, or local law.

All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.