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Quality Specialist 2 - Product Surveillance

  • GE Healthcare
  • Experienced
  • Posted 1/22/2018 6:56:14 AM
  • 3040916
  • Job Function: Quality
  • Business Segment: Healthcare Quality
Location(s): China; JiangSu; Wuxi


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.

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 proces

Qualifications/Requirements:
Qualifications : 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
4. Identify and report any compliance gaps related to the full Quality System Regulation (QSR) and Current Good Manufacturing Practices (CGMP) requirements 5. Ensure zero repeat findings from previous internal and external audits within area of responsibility 6. Timely complaint handling and reporting 7. Provide objective evidence of complaint handling process through compliant documentation

Qualifications: 1. Bachelor’s degree in Engineering; or high school diploma/GED and minimum 2 years work experience in Quality or Regulatory Assurance related field 2. Minimum 2 years work experience in biomedical, electrical, mechanical or software product development and design

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
to identify and implement solutions to complex problems 15. Prior experience working with Microsoft Office products 16. Working knowledge of GEHC products

Desired Characteristics:
1. Product-specific knowledge 2. Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes 3. Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc. 4. Demonstrated knowledge of 21CFR Part 820 5. Ability to demonstrate GEHC Growth Values 6. Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment 7. Ability to work independently & in a team setting 8. 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). 9. Excellent interpersonal, organizational, and influencing skills 10. Familiarity with the application of medical device as it relates to patient safety
11. Ability to analyze and process data, and draw the appropriate conclusions 12. Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems 13. Ability to analyze and process data, and draw the appropriate conclusions 14. Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems 15. Prior experience working with Microsoft Office products 16. Working knowledge of GEHC products

Locations: China; JiangSu; Wuxi

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.


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