13 days old

Manager, Risk Management

Abbott
Temecula, CA 92590

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

Subject Matter Expert providing product safety Risk Management guidance and direction to all areas associated with the design and manufacture of AVD products.

RESPONSIBILITIES:

  • Develop, implement and maintain a risk management process in the Quality System that conforms with ISO14971 across product realization by providing strategic and tactical direction
  • Maintain a sound, consistent and sustainable approach to risk management
  • Manage device safety risk by coaching and mentoring R&D development teams to prepare risk management deliverables.
  • Coach and mentor teams to create and maintain risk management records compliant with International Standard ISO14971 and Divisional procedures.
  • Define best practices to aid in the implementation of risk management requirements
  • Provide guidance and formal training to product teams regarding risk identification assessment, control and communication.
  • Maintain, develop methods, tools, procedures to conduct risk management activities  
  • Mentor, coach and train new product development teams and sustaining engineering teams to create or maintain product risk assessments
  • Mentor, coach and train engineering staff to prepare Health Risk Assessments
  • Support site audits and inquiries from regulators as it relates to product risk management  

    ACCOUNTABILITY

    • This position will work under Product Development direction and will report to the Sr. Manager, Risk Management.
    • Effective risk management improves product safety, consistency and reliability.
    • Risk management is a required process to demonstrate compliance and regulations such as CFR and MDD/MDR.

      EDUCATION

      Bachelor’s Degree - Life science or engineering degree preferred to understand and interpret technical issues; Master's preferred.

      • Minimum of (3) years
      • Experience in product safety risk management in research/engineering, new product development, operations, and/or complaint handling.
      • Experience with risk management (ISO 14971) required. Experience should include work with regulations and standards related to medical devices as it relates to product design, development and testing.
      • Knowledge of devices used for PTCA and PTA is desirable.  Knowledge of IEC60601-1 or electrical safety desired.","title":"Manager, Risk ManagementDivision: AVD Vascular
        Travel: Yes, 25 % of the Time
        Medical Surveillance: No
        Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Categories

Posted: 2019-08-05 Expires: 2019-09-08

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Manager, Risk Management

Abbott
Temecula, CA 92590

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