Total 2 system technician job vacancies in Quality Assurance / Control category in d17 loyang changi

Job Description

To perform inspection by using CMM & other measuring equipments

To ensure parts are according to customer's requirements

Job Requirements

Higher NITEC level in technical engineering or GCE 'O' level

Minimum 1 year related working experiences

Able to operate CMM machine independently is an advantage

Able to commit overtime

Good team player

Independent

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
• Proficiency in MS Office.