Ling Jin

WORK HISTORY

EDUCATION

SKILLS

ABOUT LING JIN

Versatile Quality and Regulatory professional with 12 years hands-on experience across medical devices, pharmaceuticals and biotechnology, ranging from start-ups to fortune 500 companies- I have worked through full product life cycle, from design and development, production, testing, distribution and post market activities- I have experience in navigating complex business and brand settings, from corporations, manufacturing, contract manufacturing, private labelling, importing and distribution- I have worked on a wide range of products from hardware to software, ranging from FDA device class 1 to 3, and EU MDR device class I, Is, Im, IIa, IIb and My professional and personal experiences have taught me the following about myself:I can efficiently build a Quality Management System from ground up- I utilize risk based thinking, ensure regulatory compliance and adopt best practices- I create and structure documentation at all levels from quality manual, quality policy, quality objectives, SOPs, work instructions, to form and template- I conduct Kaizen workshops to engage process SME and provide them sense of ownershipI can effectively align, lead and grow global supplier quality team and project teams- I keep team members informed, interested and inspired- I lead by example by building trust and respect, and fostering a positive work culture- I use SWOT analysis to allocate best resources and help team members to grow and develop.I educate, refine and drive myself to be better- I am constantly learning and aiming for being proactive than reactive- I am open minded and always explore for continuous improvement- I stay calm and focused when faced with adversityMY EXPERTISEQMS | Audits | Supplier Quality | CAPA | Investigations | Quality Metrics | Product Launch & TransferPROFESSIONAL CERTIFICATIONS: ASQ CQA, Certified AQS ISO13485:2016 MDSAP Lead Auditor, Certified Medical System Lead Auditor by Global Exemplar, MDR Transition