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    Quality Assurance Associate - Irvine, United States - Inari Medical

    Inari Medical
    Inari Medical Irvine, United States

    2 weeks ago

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    Description

    The Quality Assurance Associate, under direct supervision, supports efficient operation of the Quality Assurance department and compliance to FDA GMP, ISO 13485, MDSAP and other applicable regulatory requirements.

    Responsibilities Organize and digitize Quality files.
    Review training records for manufacturing personnel.
    Compile device history records and release lots into inventory.
    Submit samples for pyrogen and bioburden testing to test labs.
    Audit activities include supporting external audits and addressing audit findings.
    Work with other members of the QA team to achieve departmental/company goals.
    Review in-process subassembly and finished product manufacturing routers (including engineering/R&D builds) for accuracy and completeness.

    Identify and implement any changes necessary to the quality systems and compliance procedures to ensure and maintain the continued suitability and effectiveness of the quality management system.

    Review documentation for International Shipments.
    Other duties as assigned.
    Qualifications High school diploma or equivalent.
    Minimum 3 years QA/QC experience.
    Detail oriented and organized.
    Good interpersonal, verbal, and written communication skills.
    Prioritize and efficiently complete tasks with consistency and accuracy.
    Proven proficiency using Microsoft Office and the Internet.
    Knowledge of 21 CFR 820, ISO 13485 and other applicable regulatory standards.
    Preferred Bachelor's degree in Engineering or related technical field preferred.
    Experience with medical device manufacturer preferred.
    Inari Medical offers competitive health and wealth benefits for our employees. The base pay range for this position is $24.00-$29.00. A range of factors, including location, skills, and experience, will be considered. Actual compensation may vary. Inari Medical, Inc. advises applicants that employment is subject to completion of a successful background check.
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