Spec 3, Quality Auditing / Systems

The Temporary QMS Documentation Remediation Specialist will provide dedicated support for Quality Management System (QMS) documentation review, remediation, harmonization, and cleanup activities for the 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: (Primary Duties, Roles, and/or Authorities)

• 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 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.

Pay Range: 38-47/hr *based on experience