Lead Specialist, Product Surveillance, Ultrasound

Job Description Summary

Manages 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.

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:

• 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.

• Facilitates complaint investigations and engages with product design owners to determine effective CAPA.

• Reviews appropriate criteria for closure of complaints.

• Collaborates and communicates metrics on status of various processes.

• Continuously works to improve the process.

• Quality Specific Goals

• Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality

Goals, and applicable laws and regulations as they apply to this job type/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

• Ensure timely complaint handling and reporting

• Ensure that safety and regulatory reports to regulators are not late

• Assure complaints are closed per procedure and specific complaint closure date

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

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

Required Qualifications:

• Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 6 years of experience AND a minimum of 2 years of experience in a formal leadership role.

Desired Characteristics

• Strongly preferred Registered Sonographer with at least 6 years of experience.

• Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.

• Product-specific knowledge.

• Advanced degree in Quality Assurance and/or Regulatory Affairs field.

• Minimum 3 years experience with 21CFR Part 803.

• Ability to demonstrate GEHC Growth Values.

• Ability to quickly assess situations and make decisions.

• Demonstrated program management or leadership skills.

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

• Ability to work independently & in a team setting.

• Excellent interpersonal, organizational, and influencing skills.

• Familiarity with the application of medical device as it relates to patient safety.

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

• 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.

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