Coord 2, Quality Document Sys Mgmt

Indotronix International Corporation • Irvine, CA

4d • Onsite

About The Position

Join a dynamic team as a Quality Document System Management Coordinator and play a crucial part in maintaining and enhancing our quality systems. This is an opportunity to work with cross-functional teams, drive process improvements, and ensure regulatory compliance for both domestic and international operations. Your expertise will directly impact the successful launch of new products and the ongoing quality of existing processes.

Requirements

• Minimum 5 years of relevant experience in quality document system management.
• Bachelor’s degree or Associate’s degree (preferably in a related field).
• Strong verbal and written communication abilities.
• Proficient with Microsoft Office Suite.
• High attention to detail and accuracy.
• Effective problem-solving skills.
• Ability to handle confidential information with discretion.
• Team-oriented with proven interpersonal relationship skills.
• Capable of building stable internal working relationships.
• Demonstrated ability to work under general supervision and follow routine instructions.

Nice To Haves

• Experience supporting audits and regulatory inspections.
• Familiarity with CAPA and Change Control processes.
• Background in medical devices or highly regulated industries.

Responsibilities

• Review APM procedures and collaborate with document owners to ensure adherence to standard procedures and regulations.
• Support and guide users through the Change Control process for both Irvine and International projects.
• Process change requests, ensuring timely and accurate documentation.
• Participate in special projects such as new product launches, change management, training assignments, records retention, CAPAs, and other quality initiatives.
• Identify areas for improvement and contribute innovative solutions for enhanced process efficiency.
• Ensure timely project completion by delivering documents at critical milestones.
• Maintain precise records and continuously improve quality system documentation.
• Track and report Change Control metrics, including document updates and periodic reviews.
• Support and participate in internal and external audits.
• Conduct regular document reviews and audits to ensure compliance.
• Act as a liaison between departments, driving consistent quality strategies and risk mitigation.
• Work independently on complex assignments, contributing to successful project outcomes.

Benefits

• Competitive pay at $55.00/hr.
• Exposure to international and multi-departmental projects.
• Opportunities for professional growth through complex assignments and cross-functional collaboration.
• Work in a supportive, team-focused environment.

What This Job Offers

• Career Level: Mid Level
• Education Level: Associate degree