Spec 3, Quality Auditing / Systems

KAYGEN•Warwick, RI

About The Position

KAYGEN is seeking a temporary QMS Documentation Remediation Specialist to support Quality Management System documentation review, remediation, harmonization, and cleanup for the BD Surgery business unit. The role assesses controlled documents for compliance, consistency, clarity, and alignment with regulatory requirements and internal standards. The specialist reviews procedures, work instructions, forms, quality manuals, and supporting records to identify gaps, redundancies, inconsistencies, and opportunities for simplification and standardization. The contractor documents findings and recommended actions, revises documents as directed, maintains remediation trackers and metrics, and supports closure of documentation-related remediation activities. The role also supports electronic document management system migration, audit readiness, inspection preparation, and remediation efforts related to regulatory observations, internal audits, quality improvement initiatives, or QMS transformation. It ensures applicable global regulations for products managed and sold by the Surgery Business Unit are incorporated into the overall BDX QMS or accounted for within the business unit QMS.

Requirements

Bachelor of Science degree in Engineering, Science, or a related discipline.
At least 5 years of experience in FDA-regulated industries.
Demonstrated experience with pharmaceutical Quality Systems (GMP) and medical device Quality Systems (QSR/QMSR and ISO 13485).
Experience authoring, revising, and remediating controlled quality system documentation.
Experience working with electronic document management systems.
Strong working knowledge of cGMP requirements, Quality System Regulation (QMSR), ISO 13485, ICH Q10, and 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 implement systemic changes to enhance product quality and business efficiency at Business Unit and Plant levels.

Nice To Haves

Direct experience supporting combination products is strongly preferred.
ASQ certification such as CQE, CQA, or CMQ/OE is preferred.
Experience with electronic document management systems such as Veeva, MasterControl, TrackWise, ComplianceWire, Teamcenter, Documentum, or Agile.

Responsibilities

Review and assess controlled QMS documentation, including policies, quality manuals, SOPs, work instructions, forms and templates, quality plans, validation-related procedures, and complaint, CAPA, audit, risk management, and change control procedures.
Reconcile and clean up documents by eliminating duplicate or obsolete documents, correcting formatting inconsistencies, standardizing terminology and definitions, improving structure and usability, and aligning references and hyperlinks.
Assess documentation against applicable regulatory requirements and internal standards, and identify compliance gaps, conflicting requirements, and areas requiring revision.
Support QMS harmonization 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 subject-matter experts to resolve documentation issues.
Maintain document review trackers and provide regular project status updates.
Support migration of documentation into electronic document management systems as required.
Assist with audit readiness and inspection preparation 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.
Ensure global regulations specific to products managed and sold by the Surgery Business Unit are incorporated into the overall BDX QMS or accounted for in the business unit QMS.
Document findings and recommended actions, update and revise documents as directed, maintain remediation trackers and metrics, and support closure of documentation-related remediation activities.