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.

As our Document Control, you will:

• 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• Help prevent the unintended use of obsolete or superseded documents.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.

The ideal candidate is dependable, accurate, and comfortable working with regulated documents and detailed records. You should enjoy keeping information organized, following procedures, and helping teams stay compliant.

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

At CardioQuip, we are dedicated to empowering people towards better healthcare. As a leading company in the medical device industry, we design and manufacture advanced cardiovascular devices that make a real difference in patients' lives. Our humble beginnings started with just two founders in a small office, and we've grown into a dynamic team that values every member's contribution. We believe in fostering an environment where our team is empowered, customer-focused, and continually striving for improvement—all while having fun along the way.

Your work helps support the quality, safety, and reliability of products used in critical healthcare environments. This role offers the opportunity to be part of a collaborative team, contribute to meaningful quality processes, and grow your experience in medical device quality and regulatory compliance.