22 days old

Product Surveillance Team Manager - Imaging

GE Energy
Bengaluru, KA 560002
Role Summary:This role combines skills in leadership, post market regulation, and product knowledge to lead a team in the complaint handling process. He/she works along with assigned product complaint handling teams in Imaging products to ensure GE Healthcare (GEHC) implements and complies with GEHC global and local procedures within the area of post market surveillance and to share best practices across the complaint handling teams.

Essential Responsibilities:1. Direct the daily workflow of a team of product surveillance professionals, providing daily direction on processing and workload balance across the products in the assigned family to drive increased efficiency in the complaint handling process. This includes hands-on Complaints processing of some of the assigned team complaints volume as needed. 2. Ensure timely complaint investigation and timely handling of complaints that represent further evaluation under 21CFR Part 803 (MDR)3. Ensuring appropriate criteria for closure of complaints is utilized within the team 4. Collect, summarize & evaluate performance metrics to identify process trends within their assigned area that may require attention to ensure the continued efficient and compliant operation of the product surveillance teams 5. Own operating mechanisms for effective trending of complaints; analyze & communicate any product trends to the Product Surveillance Manager for further action 6. Educate, train, & advise CHU team members, engineers and other professionals on the complaint process in order to drive quality product complaint records and timely complaint processing 7. Support and lead continuous improvement/LEAN activities 8. Drive improvements in complaint documentation to meet regulatory requirements Management Reviews 9. Continuously working to improve the process

Qualifications/Requirements:1. Bachelors degree in Engineering, Clinical, Health Sciences or business field and minimum 5 years experience in medical device in an Engineering, Manufacturing, field Service, Quality/Regulatory related roles. 2. Demonstrated knowledge of Quality Management System (QMS) & in-depth understanding of site level products & related processes 3. Ability to work effectively and multi-task in a fast paced environment with competing priorities 4. Ability to prioritize, plan & evaluate workload to meet business goals and regulatory requirements 5. Demonstrated ability to effectively communicate CHU related activities and requirements 6. Demonstrated collaboration, negotiation & conflict resolution skills 7. Exceptional analytical, problem solving & root-cause analysis skills 8. Excellent team-player with global mindset and the ability to work with remotely located team members 9. Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English, tailoring communication methods to intended audience requirements 10. Proficiency with Microsoft Office applications, including Excel, PowerPoint and Word

Desired Characteristics:1. Advanced degree in Quality Assurance and/or Regulatory Affairs related field 2. Regulatory Affairs Certification (RAPS)3. Demonstrated ability to drive change, challenge the status quo and champion new activities, stimulating others to change and manage implementation effectively 4. Demonstrated program management and/or team leadership skills 5. Demonstrated knowledge of continuous improvement methodologies 6. Working knowledge of GEHC products 7. Excellent interpersonal, organizational, communication and influencing skills

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 GEs mission and deliver for our customers. www.ge.comAdditional Locations:India;Bengaluru;

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Posted: 2020-05-12 Expires: 2020-07-01

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Product Surveillance Team Manager - Imaging

GE Energy
Bengaluru, KA 560002

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