Salt Lake City, Utah, USA
11 hours ago
Associate Specialist, Product Surveillance, Surgery
Job Description SummaryThis role manages complaint handling activities and supports key Quality & Regulatory areas to ensure safe and effective products in the install base across GE Healthcare. Developing conceptual knowledge of professional discipline. May include support roles with specialized expertise or technical knowledge in broad 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

Essential 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.Key contributor as part of a complaint handling unitIdentifying complaints that represent further regulatory evaluationResolves issues using established procedures. Consults People Leader or more senior team members for issues outside of defined parameters.Collaborates with others to solve issues. Develops strong customer relationships and serves as the interface between customer and GE. Exchanges technical information, asks questions and checks for understanding.Handles simple data entry work requiring face value check and correction.Continuously working to improve the process

Qualifications/Requirements

Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 6 years of experience in a Quality or Regulatory Assurance related field), OR Associate's Degree with 4 years of experience in a Quality or Regulatory Assurance related field.

Desired Characteristics

Excellent interpersonal, organizational, and influencing skills​Familiar with 21CFR Part 820 and 803 (MDR)Ability to respectfully communicate and collaborate with team members and customersAbility to work independently & in a team settingExcellent verbal, written, and presentation skills with the ability to communicate business issues clearlyAt least 1-year experience in medical device or pharmaceutical industry in an Engineering, Quality or Regulatory related roleFamiliarity with the application of medical device as it relates to patient safety

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.

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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: Yes

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