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.
Role Summary: The QA Leader will manage quality systems, processes, and procedures to assure product safety and quality by driving business alignment to correct industry requirements and business objectives by managing quality system design, controls, and continuous improvement
Essential Responsibilities: • Establishing, maintaining and improving QMS of medical device trade company to meet CFDA GSP and ISO13485/9001 requirements • Accountable for assisting the Quality Assurance Site Manager to ensure/follow up/implement corrective actions that are raised by deviations, internal audit or regulatory inspection • Responsible for managing processes and procedures to assure product quality and safety • Responsible for engaging strong intradepartmental and cross-functional/organizational relationships to drive Quality System Requirements (QSRs) • Owning the development and maintenance of policies and procedures for departmental functions • Planning and conducting internal audits • Supporting local programs and quality issue resolution • Maintaining data in Shanghai CFDA Medical Device Traceability System • Influencing site compliance to Quality policy, Quality Management System procedures • Influencing participation in compliance to internal and external regulations • Influencing quality system metrics such as Corrective and Preventive Action, training metrics, completion and complaint resolution metrics
Qualifications/Requirements: 1. Demonstrated experience in the medical device or pharmaceutical industry and knowledge of CFDA quality system regulations and policies 2. Demonstrated ability to develop & lead process implementation & improvement in a team environment 3. Experience with some or all of the following: Design controls, design verification and validation activities Production and process controls CAPA, complaints and risk management Understanding of product quality improvement using tools such as Six Sigma, DFR Experience performing internal audits 4. Demonstrated effective interpersonal and networking skills 5. Prior experience using word processing, spreadsheet, and presentation software 6. Demonstrated ability to successfully comprehend & carry out/execute actions 7. Effective oral and written communication skills 8. Analytical & problem-solving skills/root-cause analysis 9. Exceptional conflict-resolution skills 10. Ability to interface with top organizational leadership and internal and external customers, responding in a professional manner 11. Ability to prioritize and drive multiple programs 12. Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others 13. Accepting constructive criticism and dealing calmly and effectively with high-stress situations. This includes continuing to persevere and remaining calm in challenging or frustrating circumstances 14. External Focus: Understanding customer needs, marketplace dynamics, industry trends, and the competitive landscape in the industry/function and considering the external impact of business activities and decisions on the external environment 15. Inclusiveness: Energizing others by building a connection with the team through personal involvement and trust and providing feedback and coaching to help develop others 16. Clear thinker: Simplifying strategy into specific actions with clear accountability, making decisions with speed and accuracy based on best available information, and communicating priorities clearly and concisely
Desired Characteristics: 1. Bachelor’s degree (or high school diploma/GED plus 4 years experience work experience) 2. 3 years experience working in a regulated medical device or pharmaceutical environment, quality control/assurance, or regulatory assurance 3. 1 year experience managing people (if QA Leader will have direct reports) 4. Ability to effectively communicate using English
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