About Us: GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry. GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE 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.
Role Summary: This role combines skills in post market regulation, statistics, and product knowledge in the process of trending and handling of incoming complaints.
Essential Responsibilities: 1. Key contributor as part of a complaint handling unit
2. Developing and implementing methods and procedures for effective trending of complaints
3. Facilitating complaint investigation
4. Engaging product design owners to determine effective CAPA
5. Identifying complaints that represent further evaluation under 21CFR Part 803 (MDR)
6. Reviewing appropriate criteria for closure of complaints
7. Owning and communicating metrics on status
8. Continuously working to improve the process
Qualifications/Requirements: 1. Bachelors degree in engineering or health sciences field; or a High School diploma/GED and minimum 2 years work experience in a Quality or Regulatory Assurance related field
Quality Specific Goals:
1. 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.
2. Complete all planned Quality & Compliance training within the defined deadlines.
3. Identify and report any quality or compliance concerns and take immediate corrective action as required
Desired Characteristics: 1. Minimum 1 year experience in medical device or pharmaceutical industry in an Engineering, Quality or Regulatory related role
2. Product-specific knowledge
3. Demonstrated knowledge of 21CFR Part 820
4. Ability to demonstrate GEHC Growth Values
5. Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment
6. Ability to work independently & in a team setting
7. 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).
8. Excellent interpersonal, organizational, and influencing skills
9. Familiarity with the application of medical device as it relates to patient safety
10. Ability to analyze and process data, and draw the appropriate conclusions
11. Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
12. Ability to analyze and process data, and draw the appropriate conclusions
13. Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
14. Prior experience working with Microsoft Office products
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