Document Control Specialist / CAPA Coordinator

Mativ • Dallas, TX

81d • Onsite

About The Position

Manages QMS documentation, change controls, SOPs, CAPAs, nonconformances, OOS investigations, and quality records within Mativ's QCBD system, ensuring compliance with ISO 13485 requirements. Supports audits, change control, training records, and continuous improvement initiatives to maintain an effective quality management system.

Requirements

• Bachelor’s degree in scientific discipline or equivalent practical experience
• 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 (GDP).
• Experience with eQMS systems
• Proficiency in root cause analysis tools (5 Whys, Fishbone, FMEA).
• Experience supporting internal, supplier, and regulatory audits.
• Strong organizational, analytical, communication, and problem-solving skills.
• Proficient in Microsoft Office Suite, particularly Excel and Word.

Nice To Haves

• Background in contract manufacturing or fast-paced production environments

Responsibilities

• Maintain Mativ’s electronic document control system, including all its modules.
• Manage controlled documents, including SOPs, work instructions, forms, specifications, and quality records within the eQMS.
• Coordinate document creation, review, approval, revision, distribution, and archival in compliance with ISO 13485 requirements.
• Administer and track CAPAs from initiation through closure, ensuring timely completion of action items.
• Investigate nonconformances, deviations, complaints, and audit findings; facilitate root cause analysis and corrective actions.
• Monitor CAPA effectiveness and maintain accurate records and status reports.
• Support change control activities and ensure proper implementation of document and process changes.
• Maintain employee training records and coordinate training related to revised procedures and quality documents.
• Support internal, supplier, customer, and regulatory audits by providing documentation and evidence of compliance.
• Generate quality metrics, trend analyses, and reports for Management Review.
• Collaborate with Manufacturing, Engineering, Regulatory Affairs, and Quality teams to drive continuous improvement and ensure compliance with quality system requirements.

Benefits

• Our employees and their families have many different needs. As a result, our benefits offer choices on many levels and are high in quality, competitive in the marketplace, and affordable.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level