ISO 13485 Document Control & CAPA Lead

Mativ; Dallas (TX); On-site; USD 70,000 - 95,000; Full time

Job summary

Mativ is seeking a Document Control Specialist / CAPA Coordinator to manage QMS documentation, CAPAs, and change controls in a highly regulated manufacturing environment in Dallas, TX. You will maintain eQMS records, support audits, and contribute to continuous improvement with cross-functional teams.

The role requires a bachelor’s degree in a scientific field and 3+ years in document control or quality systems, with strong roots in ISO 13485, GDP, and cGMP practices.

Qualifications

• Bachelor’s degree in scientific discipline or equivalent practical experience.
• 3+ years of document control, CAPA, or quality systems in a regulated manufacturing environment.
• Knowledge of ISO 13485, CAPA, change control, and GDP.
• Experience with eQMS systems.
• Proficiency with root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA).
• Experience supporting internal, supplier, and regulatory audits.
• Strong organizational, analytical, communication, and problem-solving skills.
• Proficient in Microsoft Office Suite (Excel, Word).

Responsibilities

• Maintain electronic document control system and modules.
• Coordinate document creation, review, approval, revision, distribution, and archival per ISO 13485.
• Administer and track CAPAs from initiation to closure; ensure timely actions.
• Investigate nonconformances, deviations, complaints, and audit findings; drive corrective actions.
• Monitor CAPA effectiveness and maintain records and status reports.
• Support change control activities and document/process changes.
• Maintain training records and coordinate training on revised procedures.
• Support audits by providing documentation and evidence of compliance.
• Generate quality metrics and trend reports for Management Review.
• Collaborate with Manufacturing, Engineering, Regulatory, and Quality teams for continuous improvement.

Skills

Document control

CAPA

ISO 13485

GDP

eQMS

Root cause analysis

Audits

MS Excel

MS Word

Education

Bachelor’s degree in scientific discipline

Job description

Mativ is seeking a Document Control Specialist / CAPA Coordinator to manage QMS documentation, CAPAs, and change controls in a highly regulated manufacturing environment in Dallas, TX. You will maintain eQMS records, support audits, and contribute to continuous improvement with cross-functional teams.

The role requires a bachelor’s degree in a scientific field and 3+ years in document control or quality systems, with strong roots in ISO 13485, GDP, and cGMP practices.