GE HealthCare Senior Associate Specialist Product Surveillance Clinical Ultrasound 

United States, Wisconsin 

260476825

Roles and Responsibilities:

• Evaluate complaints from patient safety perspective and identify complaints that require further evaluation according to global regulations, including 21CFR part 820.198, 803 (MDR), MDD/MDR, ISO 13485, etc.

• Assess risk by providing guidance on clinical workflow and how products are used to identify potentially hazardous situations.

• Manage risk by identifying product safety issues; triage complaints for further investigation.

• Perform complaint closure according to set criteria and monitor through quality metrics.

• Ensures on time submissions of safety and regulatory reports to regulators.

• Provides objective evidence of complaint handling process through compliant documentation.

• Ensure zero repeat findings from previous internal and external audits within area of responsibility.

• Analyze data on patient safety and risk, ensuring compliance with applicable postmarket regulations

• Collaborates with Medical Director and provides clinical expertise into Risk Management process.

• Support business during internal and external audits of GE Healthcare’s Quality Management System (QMS).

• Handles complaints that may require in-depth collaboration with other areas of the business, examples may include cybersecurity, new product, etc.

• Broadens knowledge of GE HealthCare’s Quality Management System and Product Surveillance activities. Uses prior experience and acquired expertise to execute timely complaint handling process.

• Has basic understanding of key business drivers and applies this understanding to accomplish Product Surveillance activities. Good understanding of how work of Product Surveillance integrates with other teams and contributes to other areas of the business.

• May have some autonomy to make decisions within a defined framework.

• Resolves issues in situations that require good knowledge and judgment within established procedures.

• Consults more senior team members for issues outside of defined policy/parameters.

• May need to request technical or clinical information from engineering, field service, clinical applications personnel, or end user/customer to solve issues.

• A job at this level requires good interpersonal skills. Explains technical and clinical information to others. Communicates effectively with upper-level leaders and/or leads projects.

• Handles simple data entry work requiring face value check and correction.

• Impacts quality of own work and the work of others on the team by participating in team audits. Identifies areas of improvement and promotes execution of standardized activities. Manages time to complete task/duties based on changing situations.

• Accountable for quality of own work, and for meeting or exceeding teams’ quality metrics.

• Continuously works on identifying opportunities to improve the complaint handling process.

• Aware of and comply with the GE HealthCare Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this position.

• Complete all planned Quality & Compliance training within the defined deadlines.

• Identify and report any quality or compliance concerns and take immediate corrective action as required.

• Ability to communicate clearly in English, verbally and in writing.

Required Qualifications:

• Bachelor's degree or equivalent in medical science, health sciences or healthcare related field and a minimum of 4 years of Ultrasound Technologist clinical experience; OR high school diploma/equivalency degree plus a minimum of 6 years of Ultrasound Technologist clinical experience

Desired Characteristics:

• GE HealthCare Product-specific knowledge – Ultrasound.

• Quality, Regulatory, or Post Market experience preferred.

• Demonstrated knowledge of ISO 13485, 21CFR part 820, ISO 14971.

• Exhibit basic understanding of clinical impact on risk management and risk assessments.

• Ability to demonstrate GE HealthCare Operating Principles.

• Ability to work independently & in a team setting.

• Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment.

• Excellent verbal, written, and presentation skills.

• Excellent interpersonal, organizational, time management, and influencing skills.

• 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.

• Ability to analyze and process data and draw the appropriate conclusions.

• Prior experience working with Microsoft Office products.

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.