Commercial Quality Specialist , Surgery (MedTech)

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Customer/Commercial Quality Job Category: Professional All Job Posting Locations: Bangkok, Bangkok, Thailand Job Description:

Overall purpose of job: Johnson & Johnson (J&J) MedTech is a provider of medical devices and diagnostics products to the market. It ensures that its products and services are scientifically sound and of high quality to help heal, cure disease, and improve the quality of life of patients and consumers. The Johnson & Johnson Commercial Quality department provides quality oversight and support to the local operating companies in the areas of strategy and planning, quality system oversight, compliance reporting, portfolio and product lifecycle management, product supply, and distribution.   Responsible for E2E support on appointed Medtech process e.g., repack/relabel, NC/CAPA, Change Control, Warehouse (DC/3PL/Distributor plus), complaint handling and support commercial quality team in execution of Quality Systems implementation and maintenance for Thailand and LCM countries (Laos, Cambodia, and Myanmar) including overseeing of 3PLs and Distribution Centers in order to meet the applicable regulatory and customer requirements and Johnson & Johnson policies and standards   This role reports solid line to the Associate Commercial Quality Manager, Johnson & Johnson MedTech Thailand.

Site quality management system activities: 1.     Adverse event and/or Health Authority reporting Responsible to report adverse events/product quality issues are reported to the health authority in the site if required by local regulation, and ensures robust processes are in place for timely reporting and closure   2.     Change Control Lead for site’s change control management. Responsible to ensure process is followed and records are managed in a timely manner with proper impact assessment, monitoring are taken. Monitors related metrics and initiates actions for improvement.   3.     Complaints management Lead the end-to-end complaint management for the site. Responsible to prepare and sign customer resolution letters when requested by complainant. Monitors trends, related metrics and initiates actions for improvement.   4.     Document control Support and ensure site compliance to document lifecycle management.   5.     Labeling and packaging Provides Quality support (such as updating quality agreements, issuing redressing instructions) in repack/relabel operation to ensure compliance to internal procedures and local regulations. Monitors related metrics and initiates actions for improvement.   6.     NC CAPA Management Lead for site’s NC/CAPA management. Responsible to ensure process is followed and records are managed in a timely manner with proper investigation, root cause analysis and corrective and preventive action taken. Monitors related metrics and initiates actions for improvement. undefined 7.     Training Management Support and ensure compliance to GxP training plan for quality system elements covered by the quality manual.   This role is also responsible for the metrics,