Quality System Specialist

Responsibilities

• 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.
• Coinciding 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.).

Requirements

• Possess the ability to work in a dynamic environment and demonstrate a high level of patience to support cross-functional teams with shifting priorities.
• Be self-motivated, able to work independently, and have a sense of ownership and accountability for the tasks assigned.

Qualifications

• 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.

Benefits

Salary - 70-85K