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Product Surveillance Lead

1.00 to 3.00 Years   Bangalore   13 Jun, 2020
GE India Technology Pvt Ltd
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryIT - Software
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

Bengaluru, IndiaExperiencedProduct Surveillance Lead -CT/PET Product Surveillance Lead -CT/PETBengaluru, 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.
Desired Characteristics:
    1. Minimum 1 year experience in medical device in an Engineering, Manufacturing, field Service, Quality/Regulatory related roles
    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
Close ApplyBengaluru, IndiaExperienced,

Keyskills :
continuous improvement facilitationfield service product designmarket regulation product knowledgecomplaint handling

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