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

Company Summary:
Since 2002, DVI Solutions has been a leading provider of audio-visual setups to help our clients communicate and collaborate better--whether it's with colleagues across the office, or partners on the other side of the world. We have presence in Singapore, Thailand, Shanghai, Hong Kong, Philippines, Malaysia and Indonesia. Our satisfied clients include corporations, government agencies, schools, retail stores, hotels and many more across Asia.

Position Summary:
The Human Resources Generalist will play a vital role in supporting a rapidly growing professional organization, supporting the company in ensuring compliance with policies and regulations and providing administrative support to the Human Resources department.

This position requires a detail-oriented individual with excellent organizational and communication skills, a strong understanding and adherence to process, and the ability to maintain confidentiality in handling sensitive information to enforce effective, scalable business processes across all functions.

Responsibilities:

Compliance and Policy:

• Stay abreast of employment laws and regulations
• Assist in the development, communication, and implementation of HR policies and procedures
• Maintain accurate and up-to-date employee records, ensuring compliance with record-keeping requirements

Administrative Support:

• Actively manage HRM System, data entry, ensuring accuracy and completeness of employee records
• Assist in the preparation and distribution of HR-related documents, such as offer letters, contracts, performance reviews, and employee handbooks
• Handle the logistics of new employee orientations and onboarding processes

Employee Relations:

• Act as a first point of contact for employee inquiries regarding HR policies, benefits, and procedures
• Assist in resolving employee relations issues by conducting initial investigations and providing support to the Director of Talent Management
• Maintain open communication channels to foster a positive work environment

Payroll and Benefits Administration:

• Support payroll, administration of employee benefit programs, including health insurance, retirement plans, and other perks
• Assist employees with benefit-related inquiries and coordinate open enrolment processes

Reporting and Special Projects:

• Generate reports as needed for HR metrics, compliance audits, and other analyses
• Assist in the planning and execution of special HR projects and initiatives
• Support in the collaboration with cross-functional teams to achieve HR-related objectives

Qualifications & Requirements:

• Human Resources, Business Administration or related degree
• At least 3 years of prior Human Resources or related work experience
• HR credentials or a demonstrated interest in obtaining credentials are preferred
• Strong understanding of Human Resources policies, concepts, procedures and employment laws
• Strong skills with HRM systems and Microsoft Office
• Highly organized with strong project management skills and ability to handle sensitive and confidential information with the highest discretion

DVI Solutions is an Equal Opportunity Employer. Qualified applicants are considered for employment without regard to age, race, color, religion, sex, national origin, sexual orientation, disability, or veteran status.