Projects

A glimpse into my hands-on work

Medical Device Quality System Establishment

1. Established quality systems for medical devices and IVD products that meet regulatory requirements while aligning with product and manufacturing process characteristics, ensuring practical implementation and product quality assurance.

2. Led quality system optimization for Fortune 500 companies, streamlining processes to make them more efficient while meeting both corporate and local market requirements.

3. Established post-market surveillance processes compliant with regulations in the US, EU, and China.

Medical Device Registration and Market Approval

1. Developed registration strategies for medical devices in China (NMPA) and the US (FDA).

2. Managed the MD product registration overall process and documentation prep.

3. Achieved Class II and III medical devices successful market approvals in both China and the US.

Supplier Selection and Management

1. Led supplier development for a wide range of products, including medical devices, industrial goods, and consumer products, covering sourcing, selection, evaluation, and ongoing monitoring.

2. Managed supplier quality control, cost negotiations, ensuring product quality and cost advantages.

3. Extensive experience in supplier qualification audits, compliance audits, and performance management.

QMS Certification and Audits

1. Led multiple FDA on-site audits, post audit remediation, Form-483 and Warning Letter responses; achieving results of zero observations.

2. Led FDA 483 response processes and corrective actions.

3. Led successful ISO 13485 and MDSAP certifications.

4. Led multiple NMPA product registration on-site audits.

International Supply Chain Development

1. Led the development of a cross-Pacific supply chain, managing the supply and sales of medical devices between China and the US.

2. Integrated resources for import/export, customs clearance, logistics, and warehousing to build an efficient, cost-effective supply chain system.

3. Managed a range of international logistics resources, including quality ocean and air freight services across continents.

4. Oversaw warehousing resources in major cities across China and the US to meet diverse business model requirements for storage and distribution.

Product Development Project Management

1. Managed multiple complex product development projects, including project planning and carrying out, team management, resource allocation, and risk management.

2. Established tailored new product development processes for different products and organizations.

3. Led the development of Class II and III medical devices, overseeing product registration and market approval.

4. Managed cross-functional international project teams.

5. Led the development of complex international supply chains.