Associate Specialist, Product Surveillance, CT PET

Job Description SummaryManages 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 purpose is to create a world where healthcare has no limits. 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.

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Job Description

Roles and Responsibilities

• Key contributor as part of a complaint handling unit
• Identifying complaints that represent further evaluation under 21CFR Part 803 (MDR)
• Reviewing appropriate criteria for closure of complaints
• Owning metrics on status
• Continuously working to improve the process
• 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 zero repeat findings from previous internal and external audits within area of responsibility.
• Timely complaint handling and reporting
• Provide objective evidence of complaint handling process through compliant documentation

Required Qualifications

• Bachelors degree in engineering or health sciences field
• Minimum 1 year experience in medical device in an Engineering, Quality or Regulatory related role

Desired Characteristics

• Product-specific knowledge of CT and PET GE HealthCare products
• Demonstrated knowledge of 21CFR Part 820
• Ability to demonstrate GEHC Growth Values
• Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment
• Ability to work independently & in a team setting   
• Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English (and where appropriate, be able to communicate in the local language verbally and in writing).
• 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
• Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
• Prior experience working with Microsoft Office products
• Working knowledge of GEHC products

Inclusive Diversity Paragraph

• 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.

Behavior Statement

• 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.

Total Reward Statement

• 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.