Lead Specialist, Product Surveillance, Clinical Ultrasound

Job Description Summary

Uses clinical product knowledge combined with skills in Product Surveillance to handle complaints, support regulatory reporting, and establish appropriate corrective and preventive actions for the safe and effective use of GE HealthCare Ultrasound products.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter.

Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description

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.
• Responsible for hazard evaluations.
• 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 post market regulations.
• Collaborates with Medical Director and provides clinical expertise into Risk Management process.
• Participates in increased skilled tasks such as in-depth data analysis, risk assessments, approval of complaint investigations (CAPA), communications with upper-level leaders, and / or leading projects.
• Ensure timely risk assessments.
• Support business during internal and external audits of GE Healthcare's Quality Management System (QMS).
• Ensure customer communications are created and issued; review customer responses for technical accuracy related to GE products.
• Communicate post market competitive data to business and site leaders.
• Develops in-depth knowledge of GE HealthCare's Quality Management System and Product Surveillance activities, including risk management and CAPA.

Uses prior experience and acquired expertise to execute timely complaint handling process.

In-depth understanding of key business drivers and applies this understanding to accomplish Product Surveillance activities.

In-depth understanding of how work of Product Surveillance integrates with other teams and contributes to other areas of the business.

• Utilizes clinical expertise and judgement to solve problems.
• Resolves issues in situations that require good knowledge and judgment within established procedures.
• Uses multiple internal sources outside of own team to arrive at decisions.
• 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 proven interpersonal skills. Communicates directly with colleges and the Ultrasound business about post market activities.

Communicates effectively with upper-level leaders. Explains clinical workflow to others, including informal guidance to new team members.

Explains complex information to others in straightforward situations.

• Handles simple data entry work requiring face value check and correction.
• Impacts projects, processes, and procedures within post market, often leading such projects. Identifies areas of improvement and promotes execution of standardized activities through participating in team, internal, and external audits.

Activities require professional judgement but may require more senior levels of guidance. Manages time to complete task / duties based on changing situations.

• Accountable for quality of own work, and for meeting or exceeding teams' quality metrics.
• 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.
• Supports business during internal and external audits of GE Healthcare's Quality Management System (QMS).
• 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 2 years of Ultrasound Technologist clinical experience;

OR high school diploma / equivalency degree plus a minimum of 6 years of Ultrasound Technologist clinical experience.

A minimum of 4 years' experience in the medical device industry or pharmaceutical industry in an Engineering, Quality, Applications / Marketing, or Regulatory related role.

Desired Characteristics :

• GE HealthCare Product-specific knowledge - Ultrasound.
• Medical device industry preferred.
• Demonstrated knowledge of ISO 13485, 21CFR part 820, 803, 806, MDD / MDR.
• 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, 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.
• Advanced Excel skills, may include Macros.
• Prior experience conducting root cause investigations and implementation of CAPA.
• Exhibit advanced understanding of clinical impact on risk management and risk assessments.
• We expect all employees to live and breathe our behaviors : to act with humility and build trust; lead with transparency;

deliver with focus, and drive ownership -always with unyielding integrity.

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.

LI-DRJ

LI-Hybrid

Additional Information

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation.

GE HealthCare is an Equal Opportunity Employer. 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