Spec 3, Quality Auditing / Systems

Job DescriptionJob Description KAYGEN is an emerging leader in providing top talent for technology-based staffing services. We specialize in providing high-volume contingent staffing, direct hire staffing and project-based solutions to companies worldwide ranging from startups to Fortune 500 and Managed Service Providers (MSP) across a wide variety of industries. Job Description: Job Title: Spec 3, Quality Auditing / Systems/ QMS Documentation Remediation Specialist Location: WarwickRhode Island02886 Duration: 12 months contract Job Description - The Temporary QMS Documentation Remediation Specialist will provide dedicated support for Quality Management System (QMS) documentation review, remediation, harmonization, and cleanup activities for the BD 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:PoliciesQuality ManualsSOPsWork InstructionsForms and TemplatesQuality PlansValidation-related proceduresComplaint, CAPA, Audit, Risk Management, and Change Control proceduresPerform document reconciliation and cleanup activities to:Eliminate duplicate or obsolete documentsCorrect formatting inconsistenciesStandardize terminology and definitionsImprove document structure and usabilityAlign references and hyperlinks Assess documentation against applicable requirements, including: 21 CFR Parts 210, 211, and 820/QMSR21 CFR Part 4 (Combination Products)ISO 13485ICH Q10EU MDR and other applicable global regulationsIdentify 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 disciplineMinimum 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 requirementsQuality System Regulation (QMSR)ISO 13485ICH Q10Risk Management principlesExcellent 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. Shift: [] Start: [] At KAYGEN, people are at the heart of everything we do. We foster a diverse, inclusive, and employee-driven culture where every individual is valued, empowered, and encouraged to bring their authentic self to work. Our candidate-first approach means we are committed to understanding your career goals and connecting you with opportunities that align with your aspirations, skills, and potential. Whether you're taking the next step in your career or searching for your dream opportunity, KAYGEN is more than a staffing partner—we're a community dedicated to helping you grow, succeed, and thrive. Join us and discover a place where your talent is recognized, your ambitions are supported, and your future is built alongside a team that invests in your success every step of the way. Our team of experienced staffing experts will work with you to find you the best opportunity. For more information, please visit us at Benefits: Free Healthcare Insurance401(k) Retirement PlanFree Life InsuranceSick Time OffAchieve your Kaizen by clicking here. A unique and exclusive talent community supported by KAYGEN, that includes programs like: Mentorship ProgramCertificationsReferralsFamily and Wellness benefitsContinuous Growth and Career Development