Ling Jin Email Address

ASQ CQA

Since our founding in 1990, CooperSurgical has researched, developed and manufactured a wide range of trusted brands that have advanced the standard of care for families. Our diversified portfolio of products and services focuses on women's health, fertility, and diagnostics. CooperSurgical Inc. is a wholly owned subsidiary of The Cooper Companies (NYSE: COO). The company, headquartered in Trumbull, CT produces and markets a wide array of products for use by women's health care clinicians.

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 III. 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 ownership I 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 adversity MY EXPERTISE QMS | Audits | Supplier Quality | CAPA | Investigations | Quality Metrics | Product Launch & Transfer PROFESSIONAL CERTIFICATIONS: ASQ CQA, Certified AQS ISO13485:2016 MDSAP Lead Auditor, Certified Medical System Lead Auditor by Global Exemplar, MDR Transition