Senior Quality Systems Engineer — Regulatory & CAPA Lead

B Capital in Penang, Malaysia is seeking qualified candidates to ensure compliance with internal quality systems and external regulatory requirements across the medical device industry. The role includes leading internal audits, CAPA management, and providing training on quality system requirements.

The ideal candidate will have a Bachelor’s degree in a relevant field, at least 9 years of manufacturing experience, and knowledge of ISO 13485, EU MDR, and FDA regulations.