Quality Documentation Specialist
Intellectt Inc, Oklahoma City, OK, United States
Job Title:
Document Management & Change Control Consultant Location:
Preferred Onsite – Raynham, MA Also open to candidates near: West Chester, PA | Warsaw, IN | Palm Beach, FL Key Responsibilities
Manage and route controlled documents using Windchill PLM Execute change control workflows and maintain document accuracy Support the full document lifecycle (creation, review, approval, release, archival) Troubleshoot document workflow issues in the PLM system Ensure documentation complies with regulatory standards Work with Quality, Regulatory, R&D, and Operations teams Regulatory Knowledge
Familiarity with: FDA 21 CFR Part 820 ISO 13485 ISO 14971 EU MDR Required Qualifications
5+ years experience in document control, change control, or PLM administration Hands-on experience with Windchill PLM (required) Experience in medical device or other regulated industries Experience supporting document migration or large documentation projects Nice to Have
Experience with Agile PLM or similar document management systems Experience with large enterprise documentation initiatives
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Document Management & Change Control Consultant Location:
Preferred Onsite – Raynham, MA Also open to candidates near: West Chester, PA | Warsaw, IN | Palm Beach, FL Key Responsibilities
Manage and route controlled documents using Windchill PLM Execute change control workflows and maintain document accuracy Support the full document lifecycle (creation, review, approval, release, archival) Troubleshoot document workflow issues in the PLM system Ensure documentation complies with regulatory standards Work with Quality, Regulatory, R&D, and Operations teams Regulatory Knowledge
Familiarity with: FDA 21 CFR Part 820 ISO 13485 ISO 14971 EU MDR Required Qualifications
5+ years experience in document control, change control, or PLM administration Hands-on experience with Windchill PLM (required) Experience in medical device or other regulated industries Experience supporting document migration or large documentation projects Nice to Have
Experience with Agile PLM or similar document management systems Experience with large enterprise documentation initiatives
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