You will be part of a dynamic team working on continuous improvement of PSA application platform-based systems. Key responsibilities include:

• managing vendors for day-to-day system support
• designing and developing system/mobile solutions to enhance business processes and digitalization objectives
• engaging key stakeholders on process design and optimization, integration with PSA systems and industry partners
• performing data support to engineers to ensure data quality and integrity for analysis and visualization
• project management, vendor management and work collaboratively with key stakeholders to ensure quality delivery with corporate governance.

Requirements

• Degree in System Engineering, Software Engineering or other ICT related fields
• Passionate about system development, process re-engineering and exploration of new technologies
• Keen in developing project and vendor management skills
• Enjoy internal and external stakeholder engagement and management
• Good analytical and problem-solving skills

SPECIFIC RESPONSIBILITIES:

• ensures all drawings, bills of materials, purchase requisitions and quality checks are completed as per project schedule and ISO 9001 processes.
• conducts Design Reviews to analyze specifications, sketches, drawings, ideas, and related data to assess factors affecting component designs and the procedures and instructions to be followed.
• confers with customer representatives to review specifications and answer questions pertaining to installation of systems.
• supports during manufacturing, assembly, de-bug, and customer buy-off.
• writes technical reports, manuals and technical support documentation
• performs a wide variety of additional functions to meet project schedules and product deliveries
• reads, understands, and acts upon mechanical drawings including piece part and assembly drawings, work instructions, and procedures
• determines manufacturing methods, techniques, and procedures as required to perform tasks as required for to ensure designs perform as required
• designs test fixtures and setups as needs arise
• communicates with vendors to support procurement and to address issues
• Responsible for any other role as assigned by the Operations Manager

QUALIFICATIONS & EXPERIENCE:

• Diploma or Degree in Mechanical / Manufacturing Engineering or an equivalent degree in related technical field desired
• 3 to 5 years relevant experience in mechanical engineering and material handling systems across various industries.
• SolidWorks or AutoCAD experience desired
• Knowledge of design techniques, tools, and principle involved in production of precision technical drawings, and models
• Knowledge of the practical application of engineering science and technology. This includes applying principles, techniques, procedures, and equipment to design and production
• Knowledge of design principles, steel and aluminium part creation, sub assembly and pneumatics.
• Ability to work independently in designing and liaising with customers on technical specifications and requirements
• Participate in and effectively communicate in group discussions and meetings
• Ability to work well in a team environment

Introduction

Nextkidney SG is a subsidiary of Nextkidney, a Dutch medical technology company based in Singapore. We are focused on the development of sorbent based dialysate regenerative device for use in a portable hemodialysis device. Our vision is to be the global leader in making portable dialysis affordable and accessible to all.

Learn more about us at www.nextkidney.com

Job description

Nextkidney SG is seeking dedicated and talented individuals with a proactive and positive ‘can-do’ attitude to join our team as QA Engineer. As part of the R&D team , you will influence the development of a new generation of home hemodialysis device, as it transitions from design to mass production.

Responsibilities:

1. QMS Management:

• Oversee and maintain the Quality Management System (QMS) to ensure compliance with regulatory standards, including ISO 13485 and 21 CFR 820.
• Develop, implement, and maintain quality policies, procedures, and processes to support the QMS.

2. Regulatory Compliance:

• Stay abreast of industry regulations and standards related to medical devices (eg, EU MDR, FDA regulations and relevant standards).
• Work closely with regulatory affairs to ensure products meet all necessary regulatory requirements.
• Assist in preparation and consolidation of technical documentation needed for both manufacturing transfer and regulatory submission.

3. Process Improvement:

• Identify areas for process improvement within the QMS and collaborate with cross-functional teams to implement changes.
• Facilitate investigation and root cause analysis of non-conformities and documentation and implementation of CAPA.
• Conduct internal audits to assess and improve compliance with established processes.

4. Risk Management:

• Participate in risk management activities for medical devices, including risk assessments, mitigation strategies, and documentation.

5. Documentation and Reporting:

• Manage the creation, review, and approval of quality-related documentation, including standard operating procedures (SOPs), work instructions, and quality records.
• Generate reports on key quality metrics and present findings to management.

6. Training:

• Provide training and orientation to employees on quality processes and procedures to ensure a thorough understanding of QMS requirements.

Qualifications:

• Bachelor's degree in a relevant field (e.g., Quality Assurance, Engineering, Biology, etc.).
• Proven experience in Quality Assurance within the medical device industry.
• In-depth knowledge of ISO 13485, FDA regulations, and other relevant standards.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Detail-oriented with a commitment to maintaining high-quality standards.
• Certification in Quality Management (e.g., ASQ Certified Quality Engineer) is a plus.

Come join our team! Please reply with your resume and expected salary

Job Description & Requirements

● Assist Project Manager in the preparation of project Capex, budget estimation and cost allocation.Assist in monitoring the budget tracking and report to Project Manager.

● Preparation of procurement plans, schedule and tracking of project procurement progress.

● Assist in Preparation of technical specification, bill of materials, RFQ for purchase of equipment, components or services required for the project.

● Coordination with procurement regarding supply and vendor issues. May work with vendors on behalf of procurement

● Assist in Preparation technical compilation and evaluation of vendors quotation.

● Preparation of documents required by the purchasing department to issue PO or matters related to purchasing and Facilitate the purchase order until PO issuance from the purchasing department.

● Prepare and monitor the procure items tracking.