Alex Jiang Email and Phone Number
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17+ years experience of Quality Management and Regulatory Affairs in global medical device companies. Expertise across design, manufacturing and commercial distribution. Led Quality Management System at all phases - setup from scratch and certification, continuous improvement, remediation and gaps fixation. Sophisticated accommodation of audits/inspections by government authorities and notified bodies. Experience at site, country, regional and global levels and collaboration of site/country lead's and functional lead's. Strong at team management and project management.Specialties: - Quality management system- Design, manufacturing and distribution- Product packaging & labelling- Process & software validation- Post market surveillance- Process improvement (lead & 6 sigma)- Project management- Global regulations- Audits
Fosun Diagnostics
View- Website:
- fosundiagnostics.com/en/web/index.do
- Employees:
- 9
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Vice President Of Quality And RegulatoryFosun DiagnosticsShanghai, China
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Vice President Of Quality & RegulatoryFosun Diagnostics Jan 2023 - Present中国 上海市- Member of executive board- Cooperate quality strategy and execution through product lifecycle- Regulatory intelligence and product global registration
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Vice President Of QualityFosun Diagnostics Apr 2021 - Dec 2022- Member of executive board- Define & execute cooperate quality strategy- Oversee quality activities across R&D, manufacturing, distribution and post-market
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Global Commercial Quality DirectorSmith & Nephew Apr 2019 - Apr 2021Shanghai, China- Manage/coordinate all quality activities in commercial distribution- Both pre-market and post-market- Across 3 regions: APAC, EMEA and LATAM/Canada -
Director, Quality Assurance - Apac&EmSmith & Nephew Oct 2014 - Mar 2019Shanghai City, China & Dubai, Uae- Member of APAC&EM Executive Team and Global QA Leadership Team - Manage Manufacturing Quality teams- Manage Design Quality teams and support all NPD/NPI projects- Lead Commercial Quality teams in APAC&EM, and all quality-related activities in global, regional and country distribution centers- Set up and maintain regional QMS and implement in all countries, and drive QMS certifications
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Senior Qa Manager - China, Iramea&LatamSmith & Nephew Jan 2012 - Sep 2014Shanghai City, China- Manage Smith & Nephew China QA function- Lead regional processes in IRAMEA (India, Russia, Africa, Middle East and Asia)- Participate in global projects representing this region- Provide audits to in-country, regional and global activities
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Qa/Ra ManagerSmith & Nephew Sep 2010 - Dec 2011Shanghai City, China- Post market surveillance- Quality control through supply chain- Quality management system- Product destination labelling (Chinese and others)- Promotional materials review- Audits
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Quality System SupervisorJohnson & Johnson Jan 2009 - Aug 2010Suzhou, Jiangsu, China- Quality management system (compliant to 21 CFR 820, ISO 13485 & China GMP)- Internal, suppliers & external audits (FDA on-site inspection)- Final inspection & product release- Software validation- Packaging & labelling validation/process- Green Belt for Six Sigma -
Quality System EngineerJohnson & Johnson Jul 2007 - Dec 2008Suzhou, Jiangsu, China- Quality system building- Agile & EtQ Reliance systems deployment- Internal audits and supplier audits- BSi ISO13485 certification- Packaging validation
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Management TraineeJohnson & Johnson Jan 2006 - Jun 2007Le Locle, Neuchâtel, Switzerland- Joined Johnson & Johnson as management trainee, to set up a new Johnson & Johnson manufacturing site- Received the start-up training in Shanghai, covering quality management system, process & products, project management, lean manufacturing, business English, cross-cultural communication, etc.- Received the on-job training in Switzerland site, of J&J worldwide quality & compliance strategy, campus QMS across 5 franchises, manufacturing control, supplier management, etc.
Alex Jiang Skills
Alex Jiang Education Details
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Instrument Science & Technology -
Mechanical Engineering & Automation
Frequently Asked Questions about Alex Jiang
What company does Alex Jiang work for?
Alex Jiang works for Fosun Diagnostics
What is Alex Jiang's role at the current company?
Alex Jiang's current role is Vice President of Quality and Regulatory.
What is Alex Jiang's email address?
Alex Jiang's email address is ya****@****ail.com
What schools did Alex Jiang attend?
Alex Jiang attended Tsinghua University, Tsinghua University.
What skills is Alex Jiang known for?
Alex Jiang has skills like Quality Systems, Document Management, Complaint Handling, Software Validation, Iso 13485, Capa, Fda, Quality Assurance, Medical Devices, Process Validation, Qsr, Fmea.
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