General Electric Product Surveillance Specialist - MS/DCAR in Bengaluru, India
Role Summary: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 unit2. Developing and implementing methods and procedures for effective trending of complaints3. Facilitating complaint investigation4. Engaging product design owners to determine effective CAPA5. Identifying complaints that represent further evaluation under 21CFR Part 803 (MDR)6. Reviewing appropriate criteria for closure of complaints7. Owning and communicating metrics on status8. 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 role2. Product-specific knowledge 3. Demonstrated knowledge of 21CFR Part 8204. Ability to demonstrate GEHC Growth Values5. Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment6. 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 safety10. Ability to analyze and process data, and draw the appropriate conclusions11. Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems12. Ability to analyze and process data, and draw the appropriate conclusions13. Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems14. Prior experience working with Microsoft Office products15. Working knowledge of GEHC products
About Us:GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE’s mission and deliver for our customers. www.ge.comAdditional Locations:India;Bengaluru;