Life Sciences Quality System Specialist

If you're detail-oriented, thrive in regulated environments, and enjoy collaborating across teams to drive quality and compliance initiatives, this could be the opportunity for you. Join a high-impact project supporting critical IVDR documentation remediation and migration efforts while helping ensure product documentation aligns with regulatory and quality system requirements. Location: Hercules, CA (Remote) Pay Rate: $40.00 - $50.00 per hour Schedule: Monday-Friday, 8:00 AM-5:00 PM Why This Role Matters This role plays a key part in supporting the final phase of a global IVDR compliance project. The Quality System Specialist will assist with reviewing, reconciling, remediating, and migrating legacy product documentation to ensure quality system compliance and documentation readiness within project timelines. What You'll Do Support completion of IVDR documentation remediation activities for legacy products Review, consolidate, and reconcile Design History Files (DHFs), technical files, requirements documentation, and risk management records Identify documentation gaps and coordinate with subject matter experts to obtain or clarify missing information Update and maintain risk management plans, reports, hazard analyses, and related documentation in accordance with established procedures Partner with Regulatory Affairs, Quality Assurance, R&D, and other stakeholders to validate documentation accuracy and resolve discrepancies Assist with migration of technical documentation into the electronic Quality Management System (eQMS) Verify document metadata, document linkage, and alignment with DHF binder structures Track assigned remediation activities and support project completion milestones What We're Looking For A current, up-to-date resume Bachelor's degree in Life Sciences, Engineering, Quality, Regulatory Affairs, or a related technical discipline; equivalent experience will be considered 5+ years of experience in a regulated quality, design control, risk management, technical documentation, or product development environmentWorking knowledge of ISO 13485, ISO 9001, FDA 21 CFR 820/QMSR, MDSAP, or similar quality system requirements Experience reviewing, organizing, reconciling, or remediating DHF, technical file, requirements, or risk management documentation Strong attention to detail with excellent organizational and project tracking skills Proven ability to collaborate effectively with cross-functional stakeholders Proficiency with Microsoft Office applications Experience with Veeva, EtQ, SAP, Salesforce, or similar systems is preferred Ability to meet compliance requirements What's In It For You Opportunity to contribute to a high-visibility global compliance initiative Fully remote work environment Competitive hourly pay Hands-on experience supporting IVDR and quality system compliance activities Exposure to cross-functional teams across Quality, Regulatory, and R&D organizations Valuable experience working within regulated medical device and life sciences environments Benefits for Manpower Associates (Upon Eligibility) Upon completion of waiting period associates are eligible for: #J-18808-Ljbffr Manpower Group (USA)