Document Control

CardioQuip • College Station, TX

2d

About The Position

Document Control CardioQuip is looking for a detail-oriented and organized Document Control to support our Quality Management System and help maintain compliance with ISO 13485 and FDA 21 CFR Part 820 requirements. In this role, you will be an important part of our Quality team, helping ensure that company documents, records, change notices, CAPAs, nonconformances, quality plans, and manufacturing records are properly controlled, maintained, and accessible. This position is ideal for someone who enjoys organization, accuracy, process improvement, and working cross-functionally with different teams.

Requirements

• Associate degree required, at a minimum.
• Strong attention to detail and accuracy.
• Excellent organizational and follow-up skills.
• Comfortable working with electronic document systems, databases, or quality software.
• Ability to manage multiple priorities and work with cross-functional teams.

Nice To Haves

• 1–2 years of administrative experience preferred.
• 1–2 years of data entry experience preferred.
• Experience in a regulated industry, medical device, manufacturing, quality assurance, or ISO environment is a plus.

Responsibilities

• Manage controlled documents, including policies, procedures, work instructions, quality records, and related documentation.
• Coordinate and track document changes through the company’s change control process.
• Help drive Change Notices to completion by monitoring progress, reporting metrics, identifying trends, and escalating issues when needed.
• Maintain accurate logs for Change Orders, CAPAs, Nonconformances, Quality Plans, and other Quality System records.
• Assign unique document identification numbers and ensure records are properly filed and maintained.
• Help prevent the unintended use of obsolete or superseded documents.
• Support CAPA and Nonconformance processes, including documentation review and historical record retrieval.
• Serve as an independent reviewer for CAPAs and assist with processing CAPAs and Nonconformances into the Quality System.
• Assist with ISO, GMP, and third-party audits.
• Review manufacturing Device History Records before release.
• Manage company signature needs through certified signature software.
• Support process improvement initiatives within the Quality Management System.
• Act as a helpful resource for employees with questions about Quality System documentation.
• Work closely with internal teams and external stakeholders to support documentation and compliance needs.
• Assist with other Quality and Regulatory responsibilities as assigned.

Benefits

• Opportunity to be part of a collaborative team.
• Contribute to meaningful quality processes.
• Grow your experience in medical device quality and regulatory compliance.

What This Job Offers

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