Quality System Specialist

Description:

• The Quality System Specialist will assist in the updating and consolidation of legacy product technical and risk management files related to IVDR. Responsibilities include:
• Facilitating risk management assessments, updating risk plans and reports, and consolidating and updating product system hazard analysis files in accordance with established company procedures and applicable standards.
• Coordinating and facilitating meetings with cross-functional stakeholders as necessary to gather information and data required for the completeness and accuracy of risk profiles for existing hazards, and identifying new risks and hazards as needed. Escalate events to Management that require additional inputs or mitigations.
• Supporting the migration of product risk management files into the eQMS system, ensuring document metadata is accurate and files are correctly linked to legacy product DHF binders in coordination with DHF migration efforts.
• Assessing legacy technical and risk documentation and identifying gaps relative to initial IVDR transitional activities versus new guidance documents and updates to global quality management procedures.
• Supporting other IVDR-related technical documentation updates and gap assessments as required, including identification of legacy design and development documentation and migration into eQMS as necessary (document scanning, etc.).
• The candidate must possess the ability to work in a dynamic environment and demonstrate a high level of patience to support cross-functional teams with shifting priorities. The individual should be self-motivated, able to work independently, and have a sense of ownership and accountability for the tasks assigned.

How You'll Make an Impact:

• The Quality System Specialist will assist in updating and consolidating legacy product design and technical documentation and risk management files related to IVDR, including:
• Facilitating risk management assessments, updating risk plans and reports, consolidating and updating product system hazard analysis files in accordance with company procedures and applicable standards.
• Coordinating and facilitating meetings with cross-functional stakeholders to obtain information and data necessary for the completeness and accuracy of risk profiles for existing hazards, and identifying new risks and hazards as needed. Escalating events to Management that require additional inputs or mitigations.
• Supporting the migration of product risk management files into the eQMS system, ensuring document metadata is accurate and files are correctly linked to legacy product DHF binders in coordination with DHF migration efforts.
• Assessing legacy design, technical and risk documentation and identifying gaps against initial IVDR transitional activities versus new guidance documents and updates to global procedures.
• Supporting other IVDR-related technical documentation updates and gap assessments as required, including migration into eQMS as necessary.
• Working in a dynamic environment and supporting cross-functional teams with shifting priorities.
• Taking initiative, working independently, and demonstrating ownership and accountability for assigned activities.

What You Bring:

• Associate degree in Biology, Chemistry, Engineering or a related field.
• 2+ years experience in regulated manufacturing or equivalent education and experience.
• Knowledge of GMP/ISO regulations (ISO 13485, MDSAP, FDA 820/210/211).
• Familiarity with device/drug/biotech manufacturing processes.
• Detail-oriented with strong organizational, project management, multitasking abilities.
• Skills in decision making, time management, communication, and computer use.
• Proficient in Microsoft Office, Visio, and Excel.
• SalesForce, Veeva, EtQ and/or SAP experience are desirable.
• Experience in product design and development and risk management a plus.