Vacancy caducado!
Job Description SummaryManages complaint handling activities and supports key Quality & Regulatory areas to ensure safe and effective products in the install base across GE Healthcare In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.Job DescriptionRoles and Responsibilities
GEHC ONLY Uses skills in post market product surveillance to handle complaints and support efforts for regulatory reporting and establishing appropriate corrective and preventive actions for the safe and effective use of GE Healthcare (GEHC) products.
Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy.
A job at this level is likely to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations.
Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance.
Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.
Required Qualifications
Bachelor 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 field
Minimum 3 years experience in medical device or pharmaceutical industry in an Engineering, Quality or Regulatory related role
Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications
Ability to analyze and process data, and draw the appropriate conclusions
Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English
Strong self-learning ability
Desired Characteristics
Three to five years previous experience with radiology software
Advanced degree in Quality Assurance and/or Regulatory Affairs field
Minimum 3 years experience with 21CFR Part 803
Proficiency with Microsoft Excel spreadsheet development and analysis
Demonstrated program management or leadership skills
Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment
Ability to work independently and in a team setting
Excellent interpersonal, organizational, and influencing skills
Familiarity with the application of medical device software as it relates to patient safety
Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
Working knowledge of GEHC software products
Strong oral and written communication skills
Demonstrated ability to analyze and resolve problems
Ability to document, plan, market, and execute programs
Established project management skills
#LI-CH3#LI-RemoteAdditional InformationGE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer (https://www.eeoc.gov/sites/default/files/2022-10/22-088EEOCKnowYourRights1020.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.GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.Relocation Assistance Provided: No
Vacancy caducado!