GE Energy

Product Surveillance Engineer

Role Summary/Purpose The Product Surveillance Engineer is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. The Product Surveillance Engineer is responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business.
Essential Responsibilities * Key contributor as part of a complaint handling unit
* Developing and implementing methods and procedures for effective trending of complaints
* Facilitating complaint investigation
* Engaging product design owners to determine effective CAPA
* Identifying complaints that represent further evaluation under 21CFR Part 803 (MDR)
* Reviewing appropriate criteria for closure of complaints
* Owning and communicating metrics on status
* Continuously working to improve the process
Qualifications/Requirements This position is open to external candidates.

* Bachelor’s degree in Engineering or high school diploma/GED and 3 years work experience in Quality or Regulatory Assurance related field
* Minimum 2 years work experience in biomedical, electrical, mechanical or software product development and design
* Ability to communicate using English
* You must be willing to take a drug test
* You must be willing to submit to a background investigation, including for
example, verification of your past employment, criminal history, and educational background.
* You must be legally authorized to work in the United States without work sponsorship at the time of hire
* You must submit your resume through gecareers.com or a job board to be considered for a specific job opening (internal candidates should apply through COS)
* You must be willing to work out of a GE office in Madison, WI
Additional Eligibility Qualifications For U.S. employment opportunities, GE hires U.S. citizens, permanent residents, asylees, refugees, and temporary residents. Temporary residence does not include those with non-immigrant work authorization (F, J, H or L visas), such as students in practical training status. Exceptions to these requirements will be determined based on shortage of qualified candidates with a particular skill. GE will require proof of work authorization. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.
Desired Characteristics * Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes
* 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.
* Demonstrated collaboration, negotiation & conflict resolution skills
* Excellent oral communication & report, business correspondence & procedure-writing skills
* Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
* Change agent with energy, passion & enthusiasm to drive change
* Exceptional analytical, problem solving & root-cause analysis skills
* Ability to multi-task & handle tasks with competing priorities effectively
* Integrity: Accepting & adhering to high ethical, moral & personal values in decisions, communications, actions & when dealing with others
* External Focus: Understanding customer needs, marketplace dynamics, industry trends, & the competitive landscape in the industry/function & considering the external impact of business activities & decisions on the external environment
* Inclusiveness: Energizing others by building a connection with the team through personal involvement & trust & providing feedback & coaching to help develop others
* Clear thinker: Simplifying strategy into specific actions with clear accountability, making decisions with speed & accuracy based on best available information & communicating priorities clearly & concisely

Additional Requirments / Information

Job Capacity:	Employee (full-time)
Minimum Education Level:	See Job Description
Visa Sponsorship:	No
Related Industries:	Production

GE Energy is one of the world's leading suppliers of power generation and energy delivery technologies in all areas of the energy industry including coal, oil, natural gas and nuclear energy as well as with renewable resources such as water, wind, solar and alternative fuels.

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