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    • quality assurance specialist - walnut creek - Tucker Parker Smith Group (TPS Group)

    Tucker Parker Smith Group (TPS Group)
    Tucker Parker Smith Group (TPS Group) walnut creek

    5 days ago

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    Description

    Quality System Specialist

    Location: Hercules, CA (Hybrid – 3 days onsite, 8am–5pm)

    Duration: 6-Month Assignment (Potential for Extension)

    Pay Rate: $40/hour.

    The Quality System Specialist will support the consolidation and updating of legacy product technical and risk management files to align with IVDR requirements. This role involves working in a fast-paced, cross-functional environment, requiring strong attention to detail, organization, and the ability to manage shifting priorities.

    Key Responsibilities:

    • Facilitate risk assessments and update associated plans and reports.
    • Consolidate and update system hazard analysis files in compliance with internal procedures and applicable standards.
    • Identify new hazards and escalate issues to management when additional inputs or mitigations are needed.
    • Coordinate and lead meetings with stakeholders to collect accurate data for risk profiles.
    • Collaborate across departments to ensure alignment on product risk documentation.
    • Support migration of product risk files into the electronic QMS (eQMS), ensuring metadata accuracy and proper linkage to legacy DHF binders.
    • Assist with scanning and migrating legacy design and development documentation.
    • Assess legacy technical and risk documentation to identify gaps relative to IVDR transitional plans and updated guidance documents.
    • Assist in updating technical documentation as required to support IVDR compliance.

    Education and Qualifications:

    • Associate degree in Biology, Chemistry, Engineering, or a related field and 2+years' experience in a regulated manufacturing environment or equivalent combination of education and experience.
    • Working knowledge of GMP and ISO regulations (e.g., ISO 13485, MDSAP, FDA 21 CFR 820/210/211).
    • Familiarity with device, drug, or biotech manufacturing processes.
    • Proficient in Microsoft Office Suite, including Excel and Visio.
    • Experience with systems such as Salesforce, Veeva, EtQ, and SAP is a plus.
    • Background in product design, development, and risk management is desirable.
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Quality assurance specialist