Document Control Specialist / CAPA Coordinator (ISO 13485)

Location: Dallas, Texas, United States; onsite role

Company

hirify.global is a global specialty materials manufacturer producing engineered components and solutions for filtration, healthcare, sustainable packaging, and other applications.

What you will do

• Manage controlled documents, SOPs, work instructions, forms, specifications, and quality records in the electronic QMS.
• Coordinate document creation, review, approval, revision, distribution, and archival in compliance with ISO 13485.
• Administer CAPAs from initiation through closure and monitor the effectiveness of corrective actions.
• Investigate nonconformances, deviations, complaints, OOS events, and audit findings; facilitate root cause analysis.
• Support change controls, employee training records, and training for revised procedures and quality documents.
• Support internal, supplier, customer, and regulatory audits and prepare quality metrics and trend reports for Management Review.

Requirements

• Bachelor’s degree in a scientific discipline or equivalent practical experience.
• At least 3 years of experience in document control, CAPA, or quality systems within a regulated manufacturing environment.
• Knowledge of ISO 13485, CAPA, change control, and Good Documentation Practices.
• Experience with eQMS systems and root cause analysis tools including 5 Whys, Fishbone, and FMEA.
• Experience supporting internal, supplier, and regulatory audits.
• Strong organizational, analytical, communication, and problem-solving skills; proficiency in Microsoft Excel and Word.

Nice to have

• Experience in contract manufacturing or fast-paced production environments.

Culture & Benefits

• Competitive benefits with coverage options for employees and their families.
• Benefits designed to meet varied employee needs and remain affordable.
• Work with Manufacturing, Engineering, Regulatory Affairs, and Quality teams on continuous improvement.