QMS ENGINEER / QMS 工程师 [ SENAI / ELECTRONIC MANUFACTURER ]
Responsible for Quality Systems and Regulatory Audits. Coordinate and support the organization with compliance to regulations and procedures.
- Host external audits from Customers, Regulatory, Certification Body, Government Agencies and etc).
- Conduct internal audits for compliance and conformance to all regulatory and quality system requirements.
- Follow up internal/external audit corrective actions implementation, evaluate progress and recommend changes in procedures or objectives, and validate their effectiveness.
- Provide training related to Quality Systems and regulatory requirement.
- Coordinate the review of Quality procedures associated with plant continuous improvement initiatives.
- Provide guidance to team, reviews of documentation related to Process or Change Validation and Quality Management System
Qualifications and Skills Required
- Candidate to possess Degree in Engineering (Electronics/Electrical/Mechanical/Material Science).
- Preferably at least 3 years with QA in PCBA or Box Build manufacturing environment in Quality Management System area.
- Knowledge in ISO 9001 and 13485.
- FDA 21 CFR Part 820 knowledge is preferred.
- ISO internal auditor certification is preferred.
- Good interpersonal, communication and presentation skills.
Kindly contact the following consultant at 07-2305453 for further details or send your resume to Mr Hanafi [ email@example.com ]