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Product Surveillance Specialist XRay/ICAR/LunarProduct Surveillance Specialist XRay/ICAR/Lunar

1.00 to 2.00 Years   Bangalore   13 May, 2020
GE India Technology Pvt Ltd
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryIT - Software
Functional AreaGeneral / Other SoftwareSales / BD
EmploymentTypeFull-time

Job Description

  • Bengaluru, IndiaExperiencedProduct Surveillance Specialist- X-Ray/ICAR/Lunar Product Surveillance Specialist- X-Ray/ICAR/LunarBengaluru, IndiaBusiness:
      GE Healthcare
    Function:
      Quality
    Role Summary/Purpose:
      This role combines skills in post market regulation, statistics, and product knowledge in the process of trending and handling of incoming complaints.
    Essential Responsibilities:
        1. Key contributor as part of a complaint handling unit
        2. Developing and implementing methods and procedures for effective trending of complaints
        3. Facilitating complaint investigation
        4. Engaging product design owners to determine effective CAPA
        5. Identifying complaints that represent further evaluation under 21CFR Part 803 (MDR)
        6. Reviewing appropriate criteria for closure of complaints
        7. Owning and communicating metrics on status
      8. Continuously working to improve the process
    Qualifications/Requirements:
      1. Bachelors degree in engineering or health sciences field; or a High School diploma/GED and minimum 2 years work experience in a Quality or Regulatory Assurance related field
    Desired Characteristics:
        1. Minimum 1 year experience in medical device or pharmaceutical industry in an Engineering, Quality or Regulatory related role
        2. Product-specific knowledge
        3. Demonstrated knowledge of 21CFR Part 82
        04. Ability to demonstrate GEHC Growth Values
        5. Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment
        6. Ability to work independently & in a team setting
        7. Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English (and where appropriate, be able to communicate in the local language verbally and in writing).
        8. Excellent interpersonal, organizational, and influencing skills
        9. Familiarity with the application of medical device as it relates to patient safety
        10. Ability to analyze and process data, and draw the appropriate conclusions
        11. Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
        12. Ability to analyze and process data, and draw the appropriate conclusions
        13. Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
        14. Prior experience working with Microsoft Office products
      15. Working knowledge of GEHC products
,

Keyskills :
product designmicrosoft office market regulationproduct knowledge complaint handlingpresentation skills pharmaceutical industry

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