杭州招聘

Business Segment

Healthcare Life Sciences

About Us

GE (NYSE: GE) works on things that matter. The best people and the best technologies taking on the toughest challenges. Finding solutions in energy, health and home, transportation and finance. Building, powering, moving and curing the world. Not just imagining. Doing. GE works. For more information, visit the company's website at www.ge.com

Role Summary/Purpose

The Product Surveillance Engineer is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. The Product Surveillance Engineer is responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business.

Essential Responsibilities

• Key contributor as part of a complaint handling unit
• Developing and implementing methods and procedures for effective trending of complaints
• Facilitating complaint investigation
• Engaging product design owners to determine effective CAPA
• Identifying complaints that represent further evaluation under 21CFR Part 803 (MDR)
• Reviewing appropriate criteria for closure of complaints
• Owning and communicating metrics on status
• Continuously working to improve the process

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/Requirements

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

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

GE医疗集团提供革新性的医疗技术和服务，以满足需求，使全世界更多的人能以更可负担的成本获得更好的医疗服务。GE专注于世界至关重要的问题，以优秀人才和领先技术致力于应对行业重大挑战。GE医疗集团在医学成像、软件和信息技术、患者监护和诊断、药物研发、生物制药技术、卓越运营解决方案等多个领域，助力专业医务人员为患者提供优质的医疗服务。