Quality Systems Coordinator I/II

About the role

Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions. The Quality Systems Coordinator I or II supports Applied Medical's quality system by maintaining standards, guidances, and regulations, supporting the learning management system, and facilitating updates to standard operating procedures (SOPs). This position is available at the Quality Systems Coordinator I or Quality Systems Coordinator II levels, with placement determined by experience. The Quality Systems Coordinator plays a hands on role in maintenance of quality documentation, training, and external requirement management.

Responsibilities

• Maintains standards, guidances, and regulations and manages the associated change control process.
• Monitors for and identifies changes in external regulatory requirements.
• Processes submitted requests for edits within the learning management system.
• Performs administrative tasks to support updates to standard operating procedures, organizing meetings and standardizing formatting for proposed changes.
• Supports external audits by retrieving and organizing requested documentation.
• Collaborates with cross-functional teams and departments to accomplish quality system tasks.
• Keeps standards, guidances, and regulations current and accurately tracked.
• Identifies external regulatory changes.
• Supports smooth, well-organized updates to standard operating procedures.
• Builds strong working relationships across departments and functions.

Requirements

• Holds an associate's degree or above in a technical discipline preferred, or brings equivalent technical expertise.
• Works independently and collaborates effectively with departmental and cross-functional team members.
• Demonstrates strong analytical skills and meticulous attention to detail.