Andrew Tong Email & Phone Number

Morrisville, North Carolina, United States

Morrisville, Nc

• Provided quality consulting services to life science companies related to compliance with FDA 21 CFRPart 820, MDD, MDR, ISO 13485, ISO 14971, IEC 62366, ISO 10993, GDP, GMP, GCP.• Prepared / reviewed / maintained Quality Management Systems for various company structures andsupported creation and maintenance of quality records to demonstrate conformance to establishedprocedures.• Supported with creation / review / maintenance of various product documentation (DHF, DMR, DHR)from a quality standpoint for over 30 medical device products, including biologics, pharmaceuticals,medical devices, and combination products, in accordance with FDA and EU MDR regulations.• Participated in quality system audits for FDA 21 CFR Part 820 and ISO 13485 compliance.• Acted as project lead for product design and development projects, guiding the design and development team through the various design product life cycle stages in accordance with established QMS and applicable regulations / standards.• Managed feedback and complaints as part of post-market surveillance for multiple combination products.

Raleigh-Durham, North Carolina Area

• Performance of quality control activities for an active commercial product in global health• Document control, SOPs, and reporting within a regulated ISO 13485 environment• Designing and conducting experiments for research purposes• Phase II design change freeze activities including scale-ups and process/product developments• Collaboration with employees to execute NCRs, PCOs, and CAPAs

Raleigh-Durham, North Carolina Area

• Lead an initiative to manufacture a class III patented hernia mesh with the assistance of local resources under the guidance of a surgeon• Organize and manage weekly meetings with deliverables set for team members• Collaborated with physical therapists on an improved device for wheel-chair bound individuals

Raleigh, Nc

• Independently worked on biological surface modification for microarrays• Explored the use of silica gold plated nanoparticles as a detection unit for biosensors

Raleigh, Nc

• Assisted in data collections for test subjects that participated in a lab study that observed metabolic energy expenditures in walking/running.