Remote IVDR Quality System Specialist

Manpower Group (USA); Hercules (CA); Remote; USD 55,000 - 69,000; Full time

Benefits offered by this job

Fully remote

Competitive hourly pay

Job summary

Manpower Group (USA) in Hercules, CA is seeking a detail-oriented Quality System Specialist to support IVDR documentation remediation and migration within a regulated environment.

This fully remote role offers visibility on a global compliance project, with responsibilities across DHFs, risk management, regulatory liaison, and eQMS migration. Ideal candidates have 5+ years in quality/regulatory settings and strong collaboration across R&D, QA, and Regulatory Affairs.

Qualifications

• Bachelor's degree in Life Sciences or a related technical discipline.
• 5+ years in regulated quality, design control, or quality documentation.
• Working knowledge of ISO 13485, ISO 9001, FDA 21 CFR 820/QMSR, MDSAP.
• Experience reviewing DHF, technical files, requirements, or risk management documentation.
• Strong attention to detail and cross-functional collaboration.

Responsibilities

• Support IVDR documentation remediation activities for legacy products.
• Review, consolidate, and reconcile DHFs, technical files, requirements, and risk records.
• Identify documentation gaps and coordinate with subject matter experts.
• Update risk management plans and hazard analyses.
• Collaborate with Regulatory Affairs, QA, R&D to validate documentation.
• Assist with migration of technical documentation into the eQMS.
• Verify document metadata and DHF binder alignment.
• Track remediation work and support project milestones.

Skills

Attention to detail

Organizational skills

Project tracking

Cross-functional collaboration

Microsoft Office

Education

Bachelor's degree in Life Sciences, Engineering, Quality, Regulatory Affairs, or related field

Tools

Veeva

EtQ

SAP

Salesforce

Job description

Manpower Group (USA) in Hercules, CA is seeking a detail-oriented Quality System Specialist to support IVDR documentation remediation and migration within a regulated environment.

This fully remote role offers visibility on a global compliance project, with responsibilities across DHFs, risk management, regulatory liaison, and eQMS migration. Ideal candidates have 5+ years in quality/regulatory settings and strong collaboration across R&D, QA, and Regulatory Affairs.