If you're a detail-oriented quality professional with experience in regulated environments, this is an exciting opportunity to contribute to critical documentation and compliance initiatives supporting medical device products. In this role, you'll collaborate with cross-functional teams to help ensure quality system documentation is accurate, complete, and aligned with regulatory requirements.
Location: Hercules, CA (Remote)
Pay Rate: $40.00 - $50.00 per hour
Employment Type: Contingent | 4.5-Month Assignment
Schedule: Monday-Friday, 8:00 AM-5:00 PMWhy This Role Matters
This position plays a key role in supporting technical documentation remediation efforts and quality system compliance activities. Your work will help ensure legacy product documentation is accurate, organized, and aligned with applicable regulatory and quality standards.
What You'll Do:- Support completion of IVDR documentation remediation activities for legacy products within established project timelines
- Review, reconcile, and organize legacy Design History Files (DHFs), technical files, requirements documentation, and risk management records
- Identify documentation gaps and partner with subject matter experts to obtain missing information and resolve discrepancies
- Update and maintain risk management plans, reports, hazard analyses, and related documentation in accordance with applicable procedures
- Coordinate with Regulatory Affairs, Quality Assurance, Research & Development, and other stakeholders to ensure documentation accuracy and completeness
- Assist with migration of documentation into the electronic Quality Management System (eQMS), including verification of metadata, document linkage, and DHF structure alignment
- Track and report progress of assigned remediation activities while maintaining strong attention to detail and organization
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 preferred, or equivalent experience 2+ years of experience in a regulated quality, design control, risk management, technical documentation, or product development environment
- Working knowledge of quality system requirements such as ISO 13485, ISO 9001, FDA 21 CFR 820/QMSR, MDSAP, or similar regulated standards
- Experience reviewing, organizing, reconciling, or remediating design history, technical file, requirements, or risk management documentation
- Strong organizational, project tracking, stakeholder management, and communication skills
- Proficiency with Microsoft Office applications
- Experience with Veeva, EtQ, SAP, Salesforce, or similar systems is preferred
- Ability to meet compliance requirements* Must be eligible and provide proof of eligibility to work in the USWhat's In It For YouCompetitive hourly pay
- Fully remote work opportunity
- Gain experience supporting high-impact regulatory and quality initiatives
- Collaborate with cross-functional teams in a regulated industry environment
- Build expertise in IVDR documentation, quality systems, and risk management processes
- Opportunity to expand experience with eQMS platforms and regulatory compliance activities
- Benefits for Manpower Associates (Upon Eligibility)
- Upon completion of waiting period associates are eligible for:
- Medical and Prescription Drug PlansDental Plan
- Supplemental Life Insurance
- Short Term Disability Insurance 401(k)
