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    Quality Assurance Engineer I - Doral, United States - Vivex Biomedical , Inc.

    Vivex Biomedical , Inc.
    Vivex Biomedical , Inc. Doral, United States

    3 weeks ago

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    Description
    Job purpose

    The Quality Assurance Engineer develops, applies, revises, and maintains quality metrics to support areas of operations at Vivex Biologics, Inc.

    The role assists in the planning, development, implementation, communication, and maintenance of Vivex's quality management systems, polices, documentation, data, and customer requirements.

    The Quality Assurance Engineer is expected to work with all departments to ensure compliance, that the final products are safe, reliable, and effective, and the successful and timely completion of projects.

    The Quality Assurance Engineer is mainly responsible for the maintenance of CAPA system items.

    They play a key role in preventing issues or fixing them if they arise by defining, monitoring, and approving the processes needed to achieve production standards.

    Duties and responsibilities
    Ability to complete well-scoped tasks with hands-on guidance.
    Initiate and/or support CAPA system items: non-conformances, deviations, corrective and preventive actions, supplier corrective actions, and complaints.

    Collaborate with CAPA system item owners and cross-functional teams to ensure they are correctly, clearly, and completely documented in compliance with procedural and technical writing requirements.

    Support data analysis and make recommendations to ensure tissue safety/quality and compliance with standards.
    Collaborate with cross-functional teams to provide Quality-related guidance, solve technical problems, and contribute to project milestones.
    Support trending analysis of relevant Quality metrics to recommend initiatives for improvement and/or corrective actions, as applicable.
    Support investigations and root cause analyses for quality-related issues, implementing effective corrective actions.
    Support change control activities by providing review and feedback ensuring compliance with applicable procedures and regulations.
    Identify potential risks associated with manufacturing processes and implement appropriate mitigation measures to minimize those risks effectively.
    Reports out on key Quality metrics during relevant meetings.
    Assist in the planning, development, review, implementation, and maintenance of Quality Assurance Policies and Standard Operating Procedures.
    Ensure personal and company compliance with all federal, state, company and regulatory bodies' regulations, policies, and procedures.
    Support validation activities, including protocol development and execution, as needed.
    Requirements
    Qualifications
    Bachelor's degree in engineering or a related technical discipline (e.g. Biology, Chemistry, etc.). Proficiency in microbiology preferred.
    Entry-level position. Minimal experience in related Engineering or Quality role preferred.
    Strong knowledge of FDA, AATB, and cGTP guidelines preferred.
    Experience in Tissue Banking, Pharmaceutical, Medical Device, or Biologics industry preferred.
    Experience with Non-Conformance, Deviation, Complaint, and Corrective and Preventive Actions (CAPAs) preferred.
    Strong knowledge of relevant software applications (Microsoft Project, Word, Excel, and PowerPoint) preferred.
    Effective oral, written, communication, and presentation skills.
    Strong analytical and problem-solving skills.
    Project management skills preferred.
    Ability to be assertive and influence others and lead significant change.
    Working conditions
    Office environment, laboratory environment, occasional clean room access, subjected to human tissue and associated hazards and biohazards.
    Physical requirements
    While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds.
    Direct reports
    No direct reports (Individual contributor role)

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