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

Scoop of work

• Assist in set-up for opening, closing and general cleaning during operations hours.
• Deliver quality customer service to all guests.
• Key orders in the Point-of-Sale system efficiently.
• Prepare and serve food and beverages according to guests’ orders efficiently.
• Maintain cleanliness of the outlet.
• Good customer service and good communication skills
• Able to work in a fast-pace environment

Requirements

• Singaporean/ PR
• Able to commit minimally 3 days a week (inclusive of 1 weekend)
• Able to work till 2am according to roster
• Able to commit for a minimum of 3 months

Responsibilities

Project Planning and Coordination:

Collaborate with the project management team to develop project plans, timelines, and budgets for HVAC projects.

Ensure compliance with project specifications, codes, and industry standards.

Coordinate and schedule project activities, subcontractors, and resources effectively.

Design Review and Analysis:

Review HVAC system design drawings and specifications to identify potential issues or improvements.

Perform engineering calculations and simulations to optimize system performance.

Provide input and technical guidance during the design phase.

Material Procurement and Vendor Management:

Assist in the procurement of HVAC materials and equipment.

Evaluate and select vendors and suppliers based on cost, quality, and reliability.

Maintain strong vendor relationships and ensure timely deliveries.

Quality Control and Inspection:

Implement quality control processes to ensure HVAC systems meet project requirements.

Conduct regular site inspections to verify workmanship and compliance.

Identify and address any deviations from project standards.

Documentation and Reporting:

Maintain accurate project documentation, including drawings, change orders, and progress reports.

Prepare and submit regular project status reports to the project management team.

Document and address any project-related issues or disputes.

Safety and Compliance:

Ensure that all HVAC installations comply with safety regulations and industry standards.

Promote a culture of safety among project team members and subcontractors.

Conduct safety audits and address any safety concerns promptly.

Client Communication:

Act as a primary point of contact for clients regarding HVAC project updates and inquiries.

Address client concerns and seek opportunities for additional services.

Budget and Cost Control:

Monitor project budgets and expenditures to ensure they align with project plans.

Identify cost-saving opportunities and implement cost control measures.

Qualifications

Bachelor's degree in Mechanical Engineering or related field.

1-2 years of experience in HVAC engineering and project management.

Strong knowledge of HVAC systems, design principles, and industry best practices.

Proficiency in AutoCAD, HVAC design software, and project management tools.

Excellent communication, leadership, and teamwork skills.

5.5 days /week

Mon - Fri : 0830 to 1730 hrs

Sat : 0830 to 1230 hrs