QMS Remediation Lead: GMP/ISO 13485 Expert

Millenniumsoft; Warwick (RI); Presencial; USD 62.000 - 69.000; Jornada completa

Descripción de la vacante

Millenniumsoft is seeking a QMS Documentation Remediation Specialist to support the Surgery business unit in Warwick, RI. The role focuses on reviewing, harmonizing, and cleaning QMS documents to ensure compliance with 21 CFR and ISO standards.

On-site position requiring collaboration with Quality, Regulatory Affairs, and Operations teams. The contractor will assess documents, update revisions, maintain trackers, and participate in remediation projects to improve documentation clarity and

Formación

• B.S. degree in Engineering/Science or related discipline.
• Minimum 5 years of experience in FDA-regulated industries.
• Experience in Pharmaceutical GMP and Medical Device QMS.
• Experience with electronic document management systems (EDMS).
• ASQ certification (CQE, CQA, CMQ/OE) preferred.

Responsabilidades

• Review and remediate QMS documentation for compliance and consistency.
• Update remediation trackers and provide status updates.
• Collaborate with Quality, Regulatory Affairs, Operations, Engineering and SMEs.
• Assist with audit readiness and inspection preparation activities.
• Support migration of documentation into electronic document management systems.

Conocimientos

cGMP

QMSR

ISO 13485

ICH Q10

Risk management

Technical writing

Documentation review

Educación

B.S. degree in Engineering/Science or related discipline

Minimum 5 years experience in FDA-regulated industries

Herramientas

Veeva

MasterControl

TrackWise

ComplianceWire

Teamcenter

Documentum

Agile

Descripción del empleo

Millenniumsoft is seeking a QMS Documentation Remediation Specialist to support the Surgery business unit in Warwick, RI. The role focuses on reviewing, harmonizing, and cleaning QMS documents to ensure compliance with 21 CFR and ISO standards.

On-site position requiring collaboration with Quality, Regulatory Affairs, and Operations teams. The contractor will assess documents, update revisions, maintain trackers, and participate in remediation projects to improve documentation clarity and