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

• Overall, responsible for project scoping, development of functional and technical specifications, project rollouts, data migration, data archiving, maintenance, system upgrading, supporting activities and vendor management.

Requirements:

• Degree in Computer Science or equivalent
• At least 2 years of experience in Microsoft technologies (.NET, C#, MVC/Javascript framework etc.)

If you are keen to apply for the position, kindly email your detailed resume in MS Word to [email protected]

Please note that only shortlisted candidates will be notified.

For more job opportunities, please visit our website at www.recruit-expert.com

EA Licence: 19C9701
Registration: R21100996

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.

Location: Bedok

Industry: Aerospace Manufacturing (US MNC)

Salary Range: $6,500 per month

This is a Contract role with Bonus and benefits.

Period: 12 Months

Job Description:

• Work with suppliers in developing parts & processes
• Experience in reading & understanding of various types of manufacturing drawings including Geometrical & Dimensional Tolerancing
• Provide technical assistance to suppliers in Manufacturing Processes, Process Sheet validation & accuracy checks (Machining / non-machining & special process suppliers).
• Knowledge in various types of special processes required for manufacturing of parts & should be capable of reading & understanding various related specifications
• Support suppliers in:
  • Understanding of drawing requirements & specifications
  • Process planning / sequencing of operations & audits of process sheets
  • Reduction in cycle time & improvement in production rates
  • Special process requirements
  • Understanding raw material requirements (AMS & related specs)
• Knowledge of tools, jigs & fixtures
• Experienced in preliminary evaluation & recommendation of potential new suppliers in terms of manufacturing capabilities
• Support the team to achieve planned goals on localization
• Hands on experience in PPAP activities such as Process Flow, PFMEA, etc. & reduction of escapes & rejects by improving handling & processing techniques
• Carryout Contract reviews, Process reviews, & audits at various suppliers.

Communication Skills

• Good written & verbal communication skills.
• Ability to communicate & present to international customer base
• Capable of multi-tasking working with different suppliers simultaneously

Education & Qualification:

• Bachelors in Engineering with 6 to 8 years of relevant experience
• Skilled in Unigraphics NX software (CAD & CAM) with hands-on experience in Milling, Turning, Grinding, etc.
• Highly advantageous to have experience in Aerospace and Defense parts manufacturing

Please submit your updated resume in Word format by using the Apply Now Button.
We regret that only shortlisted candidates will be notified

Email resume to [email protected]

People Profilers Pte Ltd, 20 Cecil Street, #08-09, PLUS Building, Singapore 049705.
Tel: 6950 9722

http://www.peopleprofilers.com
EA License Number: 02C4944
Registration Number: R1111371
Posting Personnel: Tiffany Ong Meng Yen