Quality Assurance Engineer - Medical Devices
11 months ago
Introduction
Nextkidney SG is a subsidiary of Nextkidney, a Dutch medical technology company based in Singapore. We are focused on the development of ..
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
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