Quality Engineer

SUMMARY
To assist the Quality Assurance function as technical support in issues affecting manufacturing. To support and drive corrective action efforts.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

. Ensure capability studies are performed on critical processes.
. Perform first article inspection and review visual aids.
. Perform defect analysis reporting.
. Perform MRB on sustained products.
. Participate in CAC meetings - support continuous improvement.
. Perform line and product audits.
. Assist Quality Engineering in APQP.
. Adhere to all safety and health rules and regulations associated with this position and as directed by supervisor.
. Comply and follow all procedures within the company security policy.

MINIMUM REQUIREMENTS
Bachelor's degree preferred or equivalent combination of education and experience.

Well verse in ISO13485:2016, MDSAP and will be advantage with knowledge of the FDA inspection and requirements.

Understanding of industry-specific regulations and standards, such as ISO 9001, ISO13485 to ensure supplier compliance.

Mandarin fluency required to liaise with Mandarin-speaking stakeholders.