QA Specialist – Commercial Quality (Singapore)

About the role

Johnson & Johnson MedTech is seeking a QA Specialist to lead commercial quality activities in Singapore. The role ensures that all products and services meet regulatory, customer, and company standards, supporting the delivery of high‑quality medical devices.

Key responsibilities

• Manage and maintain the site Quality Management System (QMS) for Singapore, including oversight of third‑party logistics providers and distributors.
• Provide quality support for acquisition and divestiture activities, handling change control processes.
• Report adverse events and product quality issues to health authorities as required by local regulations.
• Ensure audit readiness and lead inspection management, coordinating pre‑ and post‑audit activities and responses.
• Lead change control management for the site, ensuring timely documentation and record keeping.
• Collaborate with cross‑functional teams to ensure compliance with Johnson & Johnson policies and local regulatory requirements (e.g., GDPMDS).

Required profile

• Experience in site quality management system implementation and maintenance within a regulated environment.
• Knowledge of local medical device regulations and standards (e.g., GDPMDS).
• Proven ability to support acquisition/divestiture and change control activities.
• Experience coordinating audits and inspections and managing adverse event reporting.

Required skills