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

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.

• 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

• 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 environment
  
  Working 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

• 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

Upon completion of waiting period associates are eligible for: