Quality Systems Coordinator: Regulatory & SOP Specialist

Applied Medical; Rancho Santa Margarita (CA); On-site; USD 33,000 - 44,000; Full time

Benefits offered by this job

Competitive pay

Benefits package

Mentorship

Wellness activities

Education reimbursement

401(k) match

Vacation & holidays

Job summary

Applied Medical, a new generation medical device company with rapid growth, is seeking a Quality Systems Coordinator I or II to support the quality system by maintaining standards, guidances, and procedures. The position placement depends on experience and supports SOP updates and external requirements.

The role involves hands-on maintenance of quality documentation, learning management system support, audits preparation, and collaboration across departments to ensure compliance and continuous

Qualifications

• Holds an associate's degree or above in a technical discipline or equivalent experience.
• Communicates clearly in written and verbal formats, including presentations.
• Works independently and with cross-functional teams.
• Demonstrates strong analytical skills and meticulous attention to detail.
• Raises and escalates issues appropriately.
• Works with internal and external customers in a service-oriented manner.

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.

Skills

Analytical skills

Attention to detail

Written & verbal communication

Team collaboration

Customer service mindset

Education

Associate degree or higher in technical discipline

Job description

Applied Medical, a new generation medical device company with rapid growth, is seeking a Quality Systems Coordinator I or II to support the quality system by maintaining standards, guidances, and procedures. The position placement depends on experience and supports SOP updates and external requirements.

The role involves hands-on maintenance of quality documentation, learning management system support, audits preparation, and collaboration across departments to ensure compliance and continuous