Quality Systems Coordinator I/II

Applied Medical•Rancho Santa Margarita, CA

2d•Onsite

About The Position

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.

Requirements

Holds an associate's degree or above in a technical discipline prefered, 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.
Raises and escalates issues appropriately.
Communicates clearly in written and verbal formats, including presentations.
Works with internal and external customers in a service oriented manner.

Nice To Haves

Brings technical writing experience.
Demonstrates familiarity with medical device standards, guidances, and regulations.

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.