Total 2 job vacancies by Fong's Engineering And Manufacturing Pte Ltd

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.

· Responsible for providing hands-on support in the analysis, design, development, testing and implementation of custom web applications using Microsoft technologies and tools such as Power Platform.

· Assist the management and maintenance of on-premise and cloud-based software systems in the company.

· Providing change management, validations and testing for existing applications and software systems.

· Provide a point of escalation with support for L1 / L2 support, and liaise with external vendors for L3 support for systems.

· Participate in external and internal audit to ensure software and systems used in the company are effective and validated.

· Create and maintain documentations and compliance for data and systems with reference to industry best practices.

· Reviewing software design architecture and updating technical documents.

Perform other tasks as assigned by the supervisor.

Experience:

• 3 or more years with RDBMS and NoSQL databases
• 3 or more years of experience with object-oriented languages (Python, JavaScript, C# .etc)
• Preferred working experience in MedTech / Manufacturing Industry

Skills

• Microsoft Certified Systems Engineer (MCSE)
• Experienced in building and maintaining software systems
• Experienced with Microsoft-based stack (M365, Power Platform, Azure, Dataverse, Microsoft SQL Server, Dynamics 365 Business Central)
• Knowledge of best practices in ICT operations and systems management
• Excellent problem solving and troubleshooting skills
• Process orientated with great documentation practices
• Communication skills, especially for translating technical concepts to non-technical business leaders
• Ability to work on a dynamic, action-focused team that has concurrent projects