General Electric Product Surveillance Engineer in Waukesha, Wisconsin

Role Summary:

This role is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. Responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business.

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 complaints 7. Owning and communicating metrics on status 8. Continuously working to improve the process

Qualifications/Requirements:

  1. Bachelors degree in Engineering; or high school diploma/GED and minimum 2 years work experience in Quality or Regulatory Assurance related field2. Minimum 2 years work experience in biomedical, electrical, mechanical or software product development and design

Desired Characteristics:

  1. Product-specific knowledge 2. Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes3. Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.4. Demonstrated knowledge of 21CFR Part 8205. Ability to demonstrate GEHC Growth Values6. Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment7. Ability to work independently & in a team setting 8. 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).9. Excellent interpersonal, organizational, and influencing skills 10. Familiarity with the application of medical device as it relates to patient safety11. Ability to analyze and process data, and draw the appropriate conclusions12. Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems13. Ability to analyze and process data, and draw the appropriate conclusions14. Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems15. Prior experience working with Microsoft Office products16. Working knowledge of GEHC products

About Us:

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; Waukesha

GE will only employ those who are legally authorized to work in the United States for this opening.