General Electric Product Surveillance Leader in Madison, Wisconsin
This role combines skills in leadership, post market regulation, and product knowledge to lead a team of analysts in the complaint handling process.
- Leading a team of analysts as part of a complaint handling unit2. Owning methods and procedures for effective trending of complaints3. Ensuring timely complaint investigation4. Engaging product design owners to determine effective CAPA5. Ensuring timely handling of complaints that represent further evaluation under 21CFR Part 803 (MDR)6. Reviewing and approving appropriate criteria for closure of complaints 7. Developing training plans, conducting training, and maintaining training records for team8. Owning and communicating metrics on status during Quality Management Reviews9. Continuously working to improve the process
- Bachelors degree in engineering or health sciences field; or a High School diploma/GED and minimum 4 years work experience in a Quality or Regulatory Assurance related field2. Minimum 3 years experience in medical device or pharmaceutical industry in an Engineering, Quality or Regulatory related role
- Product-specific knowledge2. Advanced degree in Quality Assurance and/or Regulatory Affairs field3. Minimum 3 years experience with 21CFR Part 8034. Ability to demonstrate GEHC Growth Values5. Ability to quickly assess situations and make decisions6. Demonstrated program management or leadership skills7. Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment8. Ability to work independently and in a team setting 9. 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).10. Excellent interpersonal, organizational, and influencing skills 11. Familiarity with the application of medical device as it relates to patient safety12. 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. Ability to analyze and process data, and draw the appropriate conclusions15. Prior experience working with Microsoft Office products16. Working knowledge of GEHC products
GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer at http://www.ge.com/sites/default/files/15-000845%20EEO%20combined.pdf . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Locations: United States; Wisconsin; Madison
GE will only employ those who are legally authorized to work in the United States for this opening.