Document Control Specialist / CAPA Coordinator

BioMed Laboratories LLC; Dallas (TX); On-site; USD 70,000 - 100,000; Full time

Job summary

Mativ is seeking a Document Control Specialist / CAPA Coordinator to manage QMS documentation, change controls, SOPs, CAPAs, nonconformances, and OOS investigations, ensuring ISO 13485 compliance within the QCBD system and supporting audits and training records.

You will maintain the electronic document control system, coordinate creation, review, approval, revision, distribution, and archival; administer CAPAs from initiation to closure; investigate issues, track effectiveness, report metrics,

Qualifications

• 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.

Responsibilities

• Maintain Mativ's electronic document control system, including all its modules.
• 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, 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.

Skills

Document control

CAPA

GDP

Education

Bachelor's degree in scientific discipline

Tools

eQMS

Job description

Mativ is a global leader in specialty materials headquartered in Alpharetta, Georgia. The Company offers a wide range of critical components and engineered solutions that connect, protect, and purify our world.

Position Title: Document Control Specialist / CAPA Coordinator Responsibilities (ISO 13485)

Location: Dallas, Texas

Description

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.

Responsibilities

MaintainMativ'selectronic 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.

Qualifications

Required

• 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.

Preferred

• Background in contract manufacturing or fast-paced production environments

Note: Theabove statements are intended to describe the general nature and level of work being performed by the incumbent. They are not intended to be construed as an exhaustive list of all responsibilities,dutiesand skills requiredofthis position

WHAT WE OFFER

Mativ benefits say a lot about how we care for each other. 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.

ABOUT MATIV

Mativ Holdings, Inc. is a global leader in specialty materials headquartered in Alpharetta, Georgia. The company connects, protects, and purifies the world every day through a wide range of critical components and engineered solutions that solve our customers' most complex challenges. We manufacture on three continents and generate sales in nearly 100 countries through our family of business-to-business and consumer product brands. The company's two segments, Filtration & Advanced Materials and Sustainable & Adhesive Solutions, target premium applications across diversified and growing end-markets, from filtration to healthcare to sustainable packaging and more. Our broad portfolio of technologies combines polymers, fibers, and resins to optimize the performance of our customers' products across multiple stages of the value chain. Our leading positions are a testament to our best-in-class global manufacturing, supply chain, and materials science capabilities. We drive innovation and enhance performance, finding potential in the impossible.