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You are a Quality System Specialist responsible for supporting the update, consolidation, and migration of legacy product technical and risk management files related to IVDR compliance. You thrive in a dynamic environment, are self-motivated, and bring ownership and accountability to your work.
This position pays: $40-$40
What you will be doing:
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Facilitating risk management assessments, updating risk plans and reports, and consolidating system hazard analysis files in accordance with company procedures and applicable standards.
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Coordinating and facilitating meetings with cross-functional stakeholders to gather necessary information and escalate events requiring management input.
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Supporting the migration of product risk management files into the eQMS system, ensuring proper metadata and linkage with DHF binders.
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Assessing legacy documentation and identifying gaps based on evolving IVDR guidance and quality procedures.
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Assisting in technical documentation updates and the migration of legacy design files into eQMS, including scanning and organization.
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Working independently while supporting teams with shifting priorities.
What you bring:
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Associate degree in Biology, Chemistry, Engineering, or a related field.
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2+ years of experience in regulated manufacturing or equivalent.
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Knowledge of GMP/ISO regulations (ISO 13485, MDSAP, FDA 820/210/211).
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Familiarity with medical device, drug, or biotech manufacturing processes.
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Strong attention to detail, organization, and multitasking skills.
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Proficiency in Microsoft Office, Excel, and Visio.
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Experience with SalesForce, Veeva, EtQ, and/or SAP is a plus.
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Understanding of product design, development, and risk management is desirable.