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 evolvement, implement gap assessment and follow up on mitigation plan implementation.
- DCC and calibration, establish maintain, implement DCC control, responsible for calibration coordination.
Qualifications
- Full-time bachelor's degree or above
- 5+ years of relevant experience of medical device QMS/quality assurance experience in regulated manufacturing environment, prefer MNC working experience.
- Practical experience of in 0-1 QMS set up and continue improvement, well understanding on QMR, CAPA, DCC, etc.
- Good understanding of GMP, ISO13485, FDA 21 CFR820, ISO9001
- Logic thinking, good communication skill, flue English, mandarin and Malay communication, basic Chinese reading
- Travelling less than 15%
