GE HealthCare Quality Specialist - Product Surveillance Engineer 

China, Guangdong Province, Yuexiu District 

407077588

Roles and Responsibilities

• GEHC ONLY Uses skills in post market regulation, statistics, engineering and product knowledge in the process of trending, evaluating and handling incoming complaints and supporting actions for regulatory reporting and establishing appropriate corrective and preventive actions for the safe and effective use of GE Healthcare (GEHC) products.
• Key contributor as part of a complaint handling unit
• Applies general knowledge of business developed through education or past experience. Understands how work of own team contributes to the area.
• Resolves issues using established procedures. Consults People Leader or more senior team members for issues outside of defined parameters.
• Collaborates with others to solve issues.
• 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
• Timely complaint handling and reporting
• Ability to manage multiple competing priorities simultaneously while meeting established deadlines.
• Continuously working to improve processes

Required Qualifications

• This role requires basic experience in the Quality & Product Surveillance Engineering. Knowledge level is comparable to a Bachelor's degree from an accredited university or college ( or a high school diploma with relevant experience).
• Work experience in biomedical, electrical, mechanical or software product development and design
• Knowledge in Imaging medical devices
• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes
• Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment
• Ability to work independently & in a team setting
• Interpersonal, organizational, and influencing skills
• Ability to analyze and process data, and draw the appropriate conclusions

Desired Characteristics

• 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).
• Working knowledge of GE Healthcare PET and CT products
• Familiarity with the application of medical device as it relates to patient safety
• Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems

Inclusion and Diversity

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.