Jianhe Chen Email
Head of QA and RA @ CathRx Limited
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Jianhe Chen Location
- Sydney, NSW, AU
Jianhe Chen Work
- 2019 -now Head of QA and RA @
- 2017 -2019 Director of RA and QA @
- 2009 -2014 QA and RA Manager (Responsible for QA only after Jun 2011) @
- 2006 -2009 Quality Assurance Manager @
- 2005 -2006 QA and RA Manager promoted to Operations Manager in Dec 2005 @
- 2003 -2005 QA and RA Manager (Operations Manager in 2004) @ Vital Diagonostics Pty Ltd
- 2001 -2003 Research Scientist @ Apollo Life Sciences
- 1994 -2001 Lab coordinator @ The University of Sydney & Australia National University
- 1984 -1990 Doctor @ XinHua Hospital, Shanghai Second Medical University
Jianhe Chen Education
- University of Adelaide
MSc
1990-1994
Jianhe Chen Skills
- ISO 13485
- Medical Devices
- Quality Systems
- Manufacturing
- Risk Management
- Compliance
- Change Management
- FDA
- GMP
- Auditing
- Regulatory Affairs
- Quality Assurance
- ISO
- Process Improvement
- Quality Management
- Diagnostics
- CAPA
- Continuous Improvement
- Clinical
- QSR
- Process Validation
- Validation
- Design Control
- Documentation
- Quality Auditing
- Life Sciences
- FMEA
- Operations Management
- EU
- 21 CFR Part 11
- 510 K
- ISO 14971
- Complaint Handling
- CE marking
- PMA
- cGMP
- Quality Engineering
- Cleaning Validation
- Supplier Quality
- Validations
- GLP
- Software Validation
- Lean Manufacturing
- Six Sigma
- Change Control
- Regulatory Requirements
- Calibration
- Management Review
- V&V
- Software Documentation
Jianhe Chen Summary
- Jianhe Chen, based in Sydney, NSW, AU, is currently a Head of QA and RA at CathRx Limited. Jianhe Chen brings experience from previous roles at Rex Bionics, Nanosonics Ltd, Unomedical, a Convatec company and Nature's Care. Jianhe Chen holds a 1990 - 1994 MSc @ University of Adelaide. With a robust skill set that includes ISO 13485, Medical Devices, Quality Systems, Manufacturing, Risk Management and more. Jianhe Chen has 2 emails on RocketReach.
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