Document Control Coordinator

Precision One Medical • Oceanside, CA

1d • $27 - $42 • Hybrid

About The Position

This role is responsible for establishing, documenting, conducting, and maintaining the company's document control system. This includes managing document approvals, distribution, changes, and storage/retrieval. The position ensures all controlled documentation is reviewed and completed per established procedures, manages the Change Control Board (CCB), and oversees the preparation, processing, and distribution of quality manufacturing documentation. Additionally, the role involves maintaining the storage system for all records, inspecting device components and finished devices, maintaining and creating inspection plans, and reviewing device history records. The Document Control Coordinator also supports the nonconforming materials system, coordinates with engineering and other departments to ensure production schedules are met, manages the company training program, and identifies continuous improvement opportunities related to document control processes. The role requires maintaining the integrity of all quality documents and records, communicating status updates to senior management, and collaborating with various departments and external stakeholders.

Requirements

• Proficient knowledge of ISO13485 and 21 CFR Part 820, Part 11.
• Proficient knowledge of Quality System Regulations ISO 14971.
• Basic blueprint reading (GD&T).
• Basic skill with precision measuring instruments (e.g. micrometers, calipers, gauges, optical comparators, etc.).
• Must be flexible and able to adapt to change.
• Strong written and verbal communication skills.
• Highly detail-oriented.
• Must be able to exercise independent judgment and discretion.
• Communicates and works well with employees of all positions.
• Project collaboration experience involving external stakeholders.
• Computer literacy with standard software applications.

Responsibilities

• Adhere to the Company’s Quality Management System to ensure compliance with applicable regulatory requirements.
• Establish, document, conduct, and maintain the company document control system, including but not limited to document approval, distribution, changes, and storage/retrieval.
• Ensure all controlled documentation is reviewed and completed per established procedures and requirements.
• Manage the Change Control Board (CCB) and any tasks associated with the processing of controlled documentation.
• Manage the preparation, processing, and distribution of quality manufacturing documentation.
• Manage and maintain the storage system for all hardcopy and electronic records, including the organization and numbering of quality system documentation.
• Inspect device components and finished devices per established inspection procedures.
• Maintain and create new inspection plans as required.
• Review and maintain completed device history records.
• Support the nonconforming materials system, including material review board (MRB) efforts.
• Coordinate activities with engineering and other departments to ensure production schedules are met by ensuring appropriate documentation is complete and ready.
• Manage the company training program, ensuring that applicable requirements are met in a timely manner.
• Identify and drive continuous improvement opportunities related to document control processes.
• Maintain the integrity of all applicable quality documents and records.
• Provide ongoing communication and regular status updates to senior management team.
• Interface and collaborate with other departments, outside vendors, stakeholders, etc.
• Perform other duties as required.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree