Product Surveillance Engineer

Job Description Summary

Manages complaint handling activities and supports key Quality & Regulatory areas to ensure safe and effective medical products in the install base across GE Healthcare. Impacts quality of own work and the work of others on the team, including analysis and documentation of complaints, presentation of trends, identification of reportable events per the various regulatory authorities in the world. The role includes close work with internal interfaces such as engineering teams, production, service, quality assurance and regulation.

Job Description

Roles and Responsibilities

• Handle complaints as part of a complaint handling unit and support efforts for regulatory reporting and establishing appropriate corrective and preventive actions for the safe and effective use of GE Healthcare products.
• Autonomy to make decisions within a defined framework. Resolves issues in situations that require good knowledge and judgment within established procedures.
• Identifying complaints that represent further evaluation under 21CFR Part 803 (MDR)
• Facilitating complaint investigations and engaging product design owners to determine effective CAPA.
  
  

Required Qualifications

• Bachelors degree in Engineering and minimum 2 years work experience in Quality or Regulatory Assurance related field.
• Minimum 2 years work experience in biomedical, mechanical, electrical or software product development and design.
  
  

Desired Characteristics

• Excellent verbal, written, presentation & influential skills with the ability to communicate Quality & Regulatory issues with cross-functional teams clearly in English.
• Ability to work independently & in a team.
• Demonstrated knowledge of 21CFR Part 820.
• Product-specific knowledge.
• Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment.
• Prior experience working with Microsoft Office products.
• Knowledge of product quality improvement tools such as six sigma, DFR, Lean etc.
  
  

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.

GE HealthCare is an Equal Opportunity Employer where inclusion matters. 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.

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

The job is open to men and women equally

Relocation Assistance Provided: No