Job Descriptions
Assist the department head of Quality in the implementation of and maintenance of the Company Quality Management Systems (QMS) in..
Job Descriptions
Assist the department head of Quality in the implementation of and maintenance of the Company Quality Management Systems (QMS) in accordance with ISO 13485 standard and other applicable regulatory requirements.
Assist the department head of Quality to coordinate external audits conducted by customers and notified/ regulatory bodies. Work with various departments to ensure timely closure of any audit findings or observations.
Coordinate Engineering Change activities in compliance with Engineering Change procedure and ensure correct revision of drawings, specifications, and documents.
Ensure all quality documents and records are kept in compliance with Document Control and Record Control procedures.
Conduct New Employees’ Orientation (NEO) Training on Quality Policy, Quality Objectives, Good Documentation Practice and Data integrity, Document Control and Record Control.
Consolidate quality data, quality issues and trends for monthly quality metrics reporting.
Assist department Head of Quality to prepare Management Review semi-annually.
Track CAPA and any actions arising from Internal Audit, coordinate with responsible parties to ensure timely closure of action items.
Liaise with 3rd party Notification or Regulatory Bodies for certification and regulatory activities. Track and monitor Regulatory Bodies, such as FDA/ HAS for regulatory updates or any changes to their requirements.
Perform other tasks as assigned by the Supervisor
Requirement:
Diploma in Engineering, Science or equivalent
Experience:
Minimum 1 year working experience in quality management systems and applications.
Knowledge and experience working within a regulated and structured environment.
Work experience as Quality System Executive in a medical device manufacturing environment. (Candidates with more experience can be considered for Senior Quality System Executive position)
Experience with handling ISO13485 audit as an auditee
Skills :
ISO13485 Internal Auditor
Root cause analysis (Kepner- Tregoe, 5-Why, 6M etc)
Problem solving techniques (eg: DMAIC/8D/PDCA/A3 application in continuous improvement)
Competent with general PC and office software application
