Total 3 manufacturing production job vacancies in Quality Assurance / Control category in Singapore

· Create quality inspection plans and work instructions for incoming, In-process or outgoing parts to ensure that components and products conform to specifications.

· Define training plan, train QC supervisors, QC technicians and QC inspectors to perform dimensional/functional inspection in accordance to work instructions.

· Perform First Article Inspection for newly inducted materials and parts.

· Perform qualification validation of equipment, processes and test methods

· Ensure the compliance of equipment and tools use during inspection in accordance to Calibration and Preventive Maintenance requirements.

· Participate in Process Failure Mode Effect and Analysis team to mitigate product risk arising from manufacturing

· Perform complaint handling, investigate root cause of complaint and perform Corrective Action and Preventive Action as necessary.

· Handle non-conformances and perform disposition of rejected parts, trend yield and rejects, investigate root cause of non-conformance and perform Corrective Action and Preventive Action as necessary.

· Maintain the manufacturing environment and perform gowning as necessary when working in controlled manufacturing environment e.g. clean room.

· Initiate and/or execute engineering changes in compliance with Engineering Change Control procedures

· Participate in external and internal audit to ensure company quality system is effective

· Participate in continuous improvement programs such as 6S program, yield improvement projects etc.

· Support new production introduction as a team member representing quality

· Perform other tasks as assigned by the supervisor

· Work experience as a quality engineer in a medical device manufacturing environment

(Candidates with Diploma in Engineering. Science or equivalent can be considered for Assistant Quality Engineer position. Candidates with more experience can be considered for Senior Quality Engineer position)

· Experience with qualification validation of equipment, processes and test methods for new product introduction

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.

· Create quality inspection plans and work instructions for incoming, In-process or outgoing parts to ensure that components and products conform to specifications.

· Define training plan, train QC supervisors, QC technicians and QC inspectors to perform dimensional/functional inspection in accordance to work instructions.

· Perform First Article Inspection for newly inducted materials and parts.

· Perform qualification validation of equipment, processes and test methods

· Ensure the compliance of equipment and tools use during inspection in accordance to Calibration and Preventive Maintenance requirements.

· Participate in Process Failure Mode Effect and Analysis team to mitigate product risk arising from manufacturing

· Perform complaint handling, investigate root cause of complaint and perform Corrective Action and Preventive Action as necessary.

· Handle non-conformances and perform disposition of rejected parts, trend yield and rejects, investigate root cause of non-conformance and perform Corrective Action and Preventive Action as necessary.

· Maintain the manufacturing environment and perform gowning as necessary when working in controlled manufacturing environment e.g. clean room.

· Initiate and/or execute engineering changes in compliance with Engineering Change Control procedures

· Participate in external and internal audit to ensure company quality system is effective

· Participate in continuous improvement programs such as 6S program, yield improvement projects etc.

· Support new production introduction as a team member representing quality

· Perform other tasks as assigned by the supervisor

· Work experience as a quality engineer in a medical device manufacturing environment

(Candidates with Diploma in Engineering. Science or equivalent can be considered for Assistant Quality Engineer position. Candidates with more experience can be considered for Senior Quality Engineer position)

· Experience with qualification validation of equipment, processes and test methods for new product introduction