Total 3 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.

Job Description:

1. Performing F.A inspection and inspection of parts and products with desktop measuring tools / CMM / Smart scope at the incoming / outgoing / in-process gate.
2. To prepare and generate standard inspection report and lead team in performing quality inspection.
3. Monitor on critical customer products, with a corrective and preventive action programs in managing customer complaints / improvement plans.
4. Administer and work on continuous improvement program in achieving good process control.
5. Provide technical guidance to group of inspectors.
6. Manage customer complaints, corrective and preventive action programs.
7. Work closely with customers and inter-department to meet the quality requirements.
8. Experience in calibrating measuring equipments.

Requirements

• Preferred to have NTC / Diploma in related engineering field.
• Required to know-how in using desktop measuring tools, and other equipment such as CMM, Smart Scope, Roundness Tester and Roughness Tester
• Computer competancy.