Lead Specialist, Product Surveillance

Job Description SummaryIn the Post Market Surveillance and Complaint Handling role, you will process medical device customer complaints and support key Quality & Regulatory areas. This role combines skills in post market regulation, and product/clinical knowledge to process customer complaints.
This is an amazing opportunity to join GE HealthCare at an entry to mid-level Post Market Surveillance role which is well suited for those with an electrical/pneumatic/mechanical design engineering degree, a clinical degree (Nurses/PAs/Techs), experienced anesthesia machine/ventilator biomeds or field service engineers, or individuals with a minimum of 7 years experience manufacturing and testing anesthesia machines or ICU ventilators.
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

• Key contributor as part of a complaint handling unit including data analysis related to post-market safety management, reporting support, record management and etc
• Ensuring timely handling of complaints that represent further evaluation and/or reporting under 21CFR Part 803 (MDR).
• Ensuring timely complaint investigation
• Reviewing and approving appropriate criteria for closure of complaints.
• A series of operations including data analysis related to post-market safety management, reporting support, record management and etc

Required Qualifications

• Bachelor's degree in engineering or health sciences field or Associates degree in engineering or health sciences field and 3 years' experience in medical device or pharmaceutical industry in an Engineering, Biomed, Service Engineering, Nursing, Quality or Regulatory related role OR High School diploma/GED and minimum 7 years' experience in medical device or pharmaceutical industry assembling and functionally testing.

Desired Characteristics

• Product-specific knowledge (anesthesia machines or critical care ventilators)
• Advanced degree in Quality Assurance and/or Regulatory Affairs field
• 3 years' experience with 21CFR Part 803
• Familiarity with the application of medical device as it relates to patient safety
• Demonstrated experience with analyzing, processing data and drawing 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.

Additional Information

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.