JOB RESPONSIBILITIES
Lead audit and inspection preparation (e.g. corporate audit, Notified div Audit, Health Authority Inspection etc.), resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
Hands on experience in creating Quality manual and mandatory procedures.
Hands on experience in creating all departmental SOPs and forms.
Manage all released documentation in support of 1SO standards.
Experience in SA8000 standard apart from the 4 standards is an added advantage.
Track all documents from initiation to final approval.
Maintain all controlled document libraries and ensure documents are posted accordingly.
Coordinating the activities of document control, including the distribution, and auditing controlled documents
Tracking and reporting on document review progress
Review, update as necessary, and re-approve documents.
Identify the changes and current document revision status.
Make relevant documents available at points of use.
Ensure the documents remain legible and readily identifiable.
Identify external documents and control their distribution.
JOB REQUIREMENTS
Possess a bachelor’s Degree in relevant discipline, preferably in Engineering / Applied Sciences.
Have more than 5 years working experience in a Manufacturing environment, with proven experience in leading audits (internal & external).
Experience with Medical Device Single Audit Program.
Knowledge in ISO 9001, ISO 13485, ISO 14001, and ISO 45001 requirements.
Auditor Certification would be added advantage.
Strong communication and organizational skills.