Quality Assurance Engineer

Direct message the job poster from SHINING 3D

People Advisor | HR Strategy, Employee Relations, Compensation & Benefits, Talent Development

This candidate will work as part of headquarter QMS team to establish QMS in the Malaysia manufacturing site including R&D, new production introduction/NPI, mass production, mass production, as well as post marketing surveillance/PMS, also maintain QMS operation effectively.

Key Responsibilities:

• Set up Malaysia QMS compliance FDA QS820, MDSAP, ISO13485, ISO9001 and headquarter QMS requirements.
• Drive for quality continuous corrective and improvement actions, build up quality culture, collaborate with counterparts and cross-functional teams at both Malaysia and headquarter.
• Oversee internal audits, management review, external audit, registration audit, implement risk management strategies to mitigate quality related risk in manufacturing.
• Closely monitor regulation ...