GE Energy


Product Surveillance Leader (1823435)
Location: Barrington, Illinois - United States
Posted: 11/13/2017

Product Surveillance Leader

Role Summary/Purpose The Product Surveillance Leader role combines skills in leadership, post market regulation, and product knowledge to lead a team of analysts in the complaint handling process. This position supports Healthcare IT's Imaging Solutions product family.
Essential Responsibilities Key responsibilities include:
Leading a team of analysts as part of a complaint handling unit
Owning methods and procedures for effective trending of complaints
Ensuring timely complaint investigation
Engaging product design owners to determine effective CAPA
Ensuring timely handling of complaints that represent further evaluation under 21CFR Part 803 (MDR)
Reviewing and approving appropriate criteria for closure of complaints
Developing training plans, conducting training, and maintaining training records for team
Owning and communicating metrics on status during Quality Management Reviews
Continuously working to improve the process
Qualifications/Requirements This position is open to internal and external candidates.

* Bachelors degree in engineering or health sciences field or a High School diploma/GED and minimum 3 years work experience in a Quality or Regulatory Assurance related field
* Minimum 2 years experience in Quality Assurance, Regulatory Affairs, or Clinical Application of a medical device product
* 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 Barrington, IL.
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 1. Strong working knowledge of Medical Device regulations
2. 3 years experience with 21CFR Part 803: Medical Device Reporting
3. 3 years experience in medical product Quality or Regulatory
4. Demonstrated Program management or leadership skills
5. Advanced degree in Quality Assurance and/or Regulatory Affairs field
6. Working knowledge of GEHC products
7. Excellent interpersonal, organizational, communication and influencing skills
8. Excellent team-player skills w/global mindset

Additional Requirments / Information

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

*GE Energy has requested along with applying online at CampusCareerCenter.com you also fill out additional information on their site. Please click 'Apply Online' to begin the application process.

* If you would like to find out more about this position or this particular hospital, please click on the 'Information' button. We realize that you may need further information even if you are not ready to apply for a job at this time.

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