Life Sciences Quality System Specialist (IVDR & eQMS)

Manpower; Hercules (CA); On-site; USD 55,000 - 59,000; Full time

Job summary

Manpower, a leader in life sciences staffing, seeks a Life Sciences Quality System Specialist in Hercules, CA to support IVDR compliance projects and quality documentation processes.

You will help remediate legacy DHF, organize design files and risk management documentation, and coordinate with SMEs to verify accuracy while enabling migration into the eQMS system and maintaining traceability across records.

Qualifications

• Bachelor’s degree or equivalent experience in life sciences, engineering, quality, regulatory, or a related technical discipline.
• Minimum of 5+ years of experience in a regulated quality environment, including design control, risk management, or technical documentation.
• Proficiency with Microsoft Office; familiarity with Veeva, EtQ, SAP, Salesforce, or similar systems is desirable.

Responsibilities

• Support IVDR technical documentation and legacy Design History File (DHF) remediation activities.
• Review, consolidate, and reconcile legacy design, risk management, and technical documentation.
• Coordinate with subject matter experts and stakeholders to obtain missing information and verify documentation accuracy.
• Assist with migration of documentation into the eQMS, ensuring proper linkage and metadata alignment.
• Track remediation activities and support project timelines to ensure timely completion of IVDR compliance efforts.

Skills

Attention to detail

Organizational skills

Stakeholder coordination

Education

Bachelor’s degree or equivalent in life sciences, engineering, quality, regulatory, or related technical discipline

Tools

Veeva

EtQ

SAP

Salesforce

Job description

Manpower, a leader in life sciences staffing, seeks a Life Sciences Quality System Specialist in Hercules, CA to support IVDR compliance projects and quality documentation processes.

You will help remediate legacy DHF, organize design files and risk management documentation, and coordinate with SMEs to verify accuracy while enabling migration into the eQMS system and maintaining traceability across records.