Life Sciences Quality System Specialist

Our client, a leader in the life sciences industry, is seeking a dedicated and detail-oriented Life Sciences Quality System Specialist to join their team. As a vital member of the Quality Assurance department supporting IVDR compliance projects, you will collaborate with cross-functional teams to ensure the accuracy and completeness of technical documentation. The ideal candidate will demonstrate strong organizational skills, meticulous attention to detail, and excellent stakeholder coordination abilities, which will enable you to thrive in this dynamic environment.

Job Title: Life Sciences Quality System Specialist

Location: Hercules, CA

Pay Range: $40.00-43.00/hr

Shift: 8am-5pm

What's the Job?

• 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 electronic Quality Management System (eQMS), ensuring proper linkage and metadata alignment.
• Track remediation activities and support project timelines to ensure timely completion of IVDR compliance efforts.

What's Needed?

• 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.
• Working knowledge of quality system standards such as ISO 13485, ISO 9001, FDA 21 CFR 820, or MDSAP.
• Experience reviewing, organizing, and remediating design history, technical files, or risk management documentation.
• Proficiency with Microsoft Office tools; familiarity with Veeva, EtQ, SAP, Salesforce, or similar systems is desirable.
• Must be eligible and provide proof of eligibility to work in the US

What's in it for me?

• Opportunity to contribute to critical compliance projects in the life sciences industry.
• Engagement in a collaborative and innovative work environment.
• Gain valuable experience working with cross-functional teams and regulatory documentation.
• Temporary assignment with a clear project timeline and deliverables.
• Supportive team culture focused on quality and continuous improvement.

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

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