Quality Documentation & Compliance Specialist

Scapa Tapes North America; Knoxville (TN); On-site; USD 70,000 - 90,000; Full time

Job summary

Mativ Holdings, Inc. is seeking a detail-oriented Quality Document Management System specialist to manage QCBD and processing of ECNs, SOPs, CAPAs, non-conformances, and regulatory reports.

You will support audits and collaborate with the Quality Manager on investigations and certifications. The role emphasizes maintaining the electronic document control system, calibrations tracking, training records, and ensuring SOPs comply with ISO 13485:2016.

Qualifications

• Bachelor's Degree, preferably in a technical field. Equivalent relevant experience may substitute for a college degree.
• Prior successful work experience, preferably in a professional or technical environment.
• Excellent writing and verbal communication skills.

Responsibilities

• Maintain an electronic document control system, including all its modules.
• Create engineering change orders for Manufacturing Specifications and SOPs and route for approval
• Monitor manufacturing and test equipment calibration status
• Maintain the Employee Training Requirements & Records
• Review current Quality Standards and Regulations, such as ISO 13485:2016, and incorporate any new requirements into the QMS documents
• Revise and update SOPs and other quality documents as necessary to ensure accuracy and relevance, or because of audits or failure investigations
• Assist the Quality Manager in handling customer and regulatory audits.
• Assist the Quality Manager in failure investigations (Non-conformances, OOS, complaints)
• Assist the Quality Manager with regulatory inquiries and certifications
• Support the Quality department during customer and regulatory audits and work on special projects as assigned.
• Other duties as assigned

Skills

Communication

Writing

Verbal skills

Education

Bachelor's degree

Job description

Mativ Holdings, Inc. is seeking a detail-oriented Quality Document Management System specialist to manage QCBD and processing of ECNs, SOPs, CAPAs, non-conformances, and regulatory reports.

You will support audits and collaborate with the Quality Manager on investigations and certifications. The role emphasizes maintaining the electronic document control system, calibrations tracking, training records, and ensuring SOPs comply with ISO 13485:2016.