• Covington, KY
    5 days ago

    Job Description

    Responsible for ensuring design quality and regulatory compliance throughout the medical-device product development lifecycle, from concept and design through verification, validation, release, and post-market activities. Leads design controls, risk management, quality reviews, CAPA, change control, and verification/validation activities while partnering with Engineering, Regulatory, Manufacturing, and other cross-functional teams to deliver safe, effective, and compliant products. Current medical-device postings emphasize design controls, ISO 13485, ISO 14971, FDA requirements, and V&V.

    • High school diploma or equivalent. Zero (0) to one (1) year warehouse experience or related experience and/or training.
    • Obtains and/or maintains appropriate licenses / training / certifications, as needed.
    • Has basic skills training in an analytical / scientific method or operational process area (e.g., material handling and management, logistics, manufacturing production).
    • Effective communication skills at a level co-workers and Team Lead/Supervisor can understand.
    • Ability to read, write, interpret and comprehend documents written in English and perform basic math calculations. Ability to perform/operate in a metrics-driven environment.
    • General computer skills.
    • Must be able to work Monday - Thursday, 8pm- 6:30am. Uses a variety of equipment such as forklifts, conveyers, cranes, handcarts, and power trucks to move materials, parts, assemblies and finished products or goods within a plant, office or warehouse.
    • May maintain records.
    • Develops skills in basic tasks, techniques and procedures within one skill area / process / method.
    • Applies basic knowledge and skills to complete routine tasks consisting of prescribed steps.
    • Works within clearly defined SOPs and / or scientific methods and adheres to quality guidelines.
    • Works under general to limited supervision.

    Numbers & Facts

    LocationCovington, KY

    Skills

    • Analysis Skillsunmatched
    • Change Controlunmatched
    • Communication Skillsunmatched
    • Computer Skillsunmatched
    • Corrective and Preventative Action (CAPA) Systemsunmatched
    • Craneunmatched
    • Cross-Functionalunmatched
    • Design Verificationunmatched
    • English Languageunmatched
    • FDA Requirementsunmatched
    • Forkliftunmatched
    • High School Diplomaunmatched
    • ISO (International Organization for Standardization)unmatched
    • Logisticsunmatched
    • Manufacturingunmatched
    • Manufacturing Requirementsunmatched
    • Material Movingunmatched
    • Materials Managementunmatched
    • Mathematicsunmatched
    • Medical Equipmentunmatched
    • Medical Productsunmatched
    • Metricsunmatched
    • Operations Processesunmatched
    • Product Developmentunmatched
    • Product Lifecycleunmatched
    • Record Keepingunmatched
    • Regulatory Complianceunmatched
    • Risk Managementunmatched
    • Scientific Methodunmatched
    • Standard Operating Procedures (SOP)unmatched
    • Team Lead/Managerunmatched
    • Validation Testingunmatched
    • Warehousingunmatched

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