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GE HealthCare Associate Specialist Product Surveillance Ultrasound India, Karnataka 903894133
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Roles and Responsibilities
Uses product knowledge combined with skills in Product Surveillance to handle complaints, support regulatory reporting, and establish appropriate corrective and preventive actions for the safe and effective use of GE HealthCare (GEHC) Ultrasound products.
Evaluate complaints from patient safety perspective and identify complaints that require further evaluation according to global regulations, including 21CFR part 820.198, 803 (MDR), MDD/MDR, ISO 13485, etc.
Assess risk by providing guidance on clinical workflow and how products are used to identify potentially hazardous situations.
Manage risk by identifying product safety issues; triage complaints for further investigation
Responsible for hazard evaluations
Perform complaint closure according to set criteria and monitor through quality metrics
Ensures on time submissions of safety and regulatory reports to regulators
Provides objective evidence of complaint handling process through compliant documentation
Ensure zero repeat findings from previous internal and external audits within area of responsibility.
Support business during internal and external audits of GE Healthcare’s Quality Management System (QMS)
Develops knowledge of GEHC’s Quality Management System and Product Surveillance activities. Uses prior experience and acquired expertise to execute timely complaint handling process.
Applies general knowledge of how the Product Surveillance team contributes to other areas of the business developed through education or past experience.
Resolves issues using established procedures.
Consults People Leader or more senior team members for issues outside of defined parameters.
Collaborates with others to solve issues.
Requests technical or clinical information from engineering, field service, clinical applications personnel, or end user/customer to solve issues.
Handles simple data entry work requiring face value check and correction.
Accountable for quality of own work and for meeting or exceeding the teams’ quality metrics
Continuously works on identifying opportunities to improve the complaint handling process
Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
Complete all planned Quality & Compliance training within the defined deadlines
Identify and report any quality or compliance concerns and take immediate corrective action as required
Ability to communicate clearly in English, verbally and in writing
Required Qualifications
Bachelor's degree in Engineering from an accredited university or college with at least 2-4 years of experience in Engineering/ Quality and good knowledge of Ultrasound/Digital Products
Desired Characteristics
GE HealthCare Product-specific knowledge
Medical Device industry experience preferred
Ability to demonstrate GEHC Growth Values
Ability to work independently & in a team setting
Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment
Excellent verbal, written, and presentation skills
Excellent interpersonal, organizational, time management skills
Familiarity with the application of medical device as it relates to patient safety
Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
Ability to analyze and process data, and draw the appropriate conclusions
Prior experience working with Microsoft Office products.
total rewardsare designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support
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