QMS Documentation Remediation Specialist - Onsite (Urgent Need)

Millenniumsoft; Warwick (RI); On-site; USD 62,000 - 69,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

cGMP

QMSR

ISO 13485

ICH Q10

Risk management

Technical writing

Documentation review

Education

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

Minimum 5 years experience in FDA-regulated industries

Tools

Veeva

MasterControl

TrackWise

ComplianceWire

Teamcenter

Documentum

Agile

Job description

Job Title - QMS Documentation Remediation Specialist

Job Location - Warwick, Rhode Island

Duration: 12 Months

Job Description

Pay rate:$45-50/hr

On site .The QMS Documentation Remediation Specialist will provide dedicated support for Quality Management System (QMS) documentation review, remediation, harmonization, and cleanup activities for the client Surgery business unit. This role will focus on assessing controlled documents for compliance, consistency, clarity, and alignment with applicable regulatory requirements and internal standards.

The successful candidate will possess hands‑on experience working within both pharmaceutical GMP, medical device and combination product quality systems and be capable of independently reviewing procedures, work instructions, forms, quality manuals, and supporting records to identify gaps, redundancies, inconsistencies, and opportunities for simplification and standardization.

The Contractor Will Be Expected To

• Review and assess assigned QMS documents.
• Document findings and recommended actions.
• Update and revise documents as directed.
• Maintain remediation trackers and metrics.
• Support closure of documentation-related remediation activities.

Job Responsibilities:

• Conduct comprehensive reviews of controlled QMS documentation, including:
• Policies
• Quality Manuals
• SOPs
• Work Instructions
• Forms and Templates
• Quality Plans
• Validation-related procedures
• Complaint, CAPA, Audit, Risk Management, and Change Control procedures
• Perform document reconciliation and cleanup activities to:
• Eliminate duplicate or obsolete documents
• Correct formatting inconsistencies
• Standardize terminology and definitions
• Improve document structure and usability
• Align references and hyperlinks
• Assess documentation against applicable requirements, including:
• 21 CFR Parts 210, 211, and 820/QMSR
• 21 CFR Part 4 (Combination Products)
• ISO 13485
• ICH Q10
• EU MDR and other applicable global regulations
• Identify compliance gaps, conflicting requirements, and areas requiring revision.
• Support QMS harmonization initiatives by comparing legacy and future-state procedures and recommending streamlined approaches.
• Collaborate with Quality, Regulatory Affairs, Operations, Engineering, Manufacturing, Supply Chain, R&D, and other SMEs to resolve documentation issues.
• Maintain document review trackers and provide regular project status updates.
• Support migration of documentation into electronic document management systems (eDMS) as required.
• Assist with audit readiness and inspection preparation activities by ensuring documentation is complete, current, and inspection-defensible.
• Participate in remediation projects associated with regulatory observations, internal audits, quality improvement initiatives, or QMS transformation efforts.
• Ensures compliance with global regulations specific to the products managed and sold by the Surgery Business Unit are incorporated into the overall QMS structure at the BDX level or, alternatively, are accounted for in the business unit QMS.

Education And Experience

• B.S. degree in Engineering/Science or related discipline
• Minimum 5 years of experience in FDA-regulated industries.
• Demonstrated experience in both:
• Pharmaceutical Quality Systems (GMP)
• Medical Device Quality Systems (QSR/QMSR and ISO 13485)
• Direct experience supporting combination products strongly preferred.
• Experience authoring, revising, and remediating controlled quality system documentation.
• Experience working within electronic document management systems (e.g., Veeva, MasterControl, TrackWise, ComplianceWire, Teamcenter, Documentum, Agile, etc.).
• ASQ certification (CQE, CQA, CMQ/OE) preferred.

Knowledge And Skills

• Strong working knowledge of:
• cGMP requirements
• Quality System Regulation (QMSR)
• ISO 13485
• ICH Q10
• Risk Management principles
• Excellent technical writing, editing, and document review skills.
• Strong attention to detail and ability to identify documentation inconsistencies and compliance gaps.
• Ability to interpret regulatory requirements and translate them into practical quality system expectations.
• Ability to understand Corporate, Business Unit and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency at the Business Unit & Plant levels.