You will be part of the Alert Monitoring Team, to monitor pro-active and reactive alerts coming from various tools, perform 24 x 7 shift duties on rotation to support monitoring functions in BMC Control-M platform.

• Monitoring – scrutinizing alerts received from our various tools and ensuring that they are properly logged and worked on.
• Incident Ticket Management – entering alerts into ticketing tool (Remedy) and updating these tickets as necessary.
• Escalation – contacting various support teams as necessary to ensure alerts are properly managed.
• Automation – look into ways to automate repetitive tasks and work with vendors and internal parties to implement automated solutions.
• Process Improvement – continuously review current processes to identify rooms for improvement including automation and job optimization.
• Documentation – create and update documentation related to Operations Monitoring
• Audit – ensure that all documentations used by the team including processes, SOP’s and work instructions are complete, accurate and up to date.
• Reporting and Communications – create and distribute reports and communications related to Operations Monitoring.

JOB REQUIREMENTS/QUALIFICATION

• Diploma or Degree in IT, Computer Science, Engineering, Information Technology or related discipline from a recognized institution.
• At least 2 years of working experience in Job Monitoring Operations
• Information Technology Infrastructure Library (ITIL) foundation certification
• Able to communicate with all levels of the organization from senior management, junior staff and technical personnel.
• Able to work in a 24x7 shift roster
• Knowledgeable in using Microsoft Excel formulas, pivot tables and macros for creating and automating reports
• Experience in BMC Control-M platform

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

Main responsibilities

As a Support Analyst, you will be part of Run Control Tower team which is a gatekeeper for Production stability & quality as well as Support Practices across CBI Subdomains. Strive for continuous improvement in order to improve the quality of service regarding Produciton matters.

The Run Control Tower has two main functions:

- Gatekeeper for the production stability & quality

- Responsible for the support practices across CBI Subdomains

The main streams of its activities are to:

- Design the processes, methodologies, define and control their operational implementation (requests, incidents, problems, intprods, changes, knowledge)

- Supervise the production activities (with reporting, governance and operational management)

- Coordination transversal IT events and operations (WIP, DRP, Crisis, Obso projects, Security topics sustainability)

- Control the transition from project to run (ORA/ CAB/ Frozen Periods/ Payment Setup)

We have a strong collaboration and proximity on daily basis with support, dev and IP and DRP teams.

We are also in touch with CAGIP and GIT production process owners and security referent and the different production communities.

We work to develop and standardize the practices accross CBI so we report on our progress and solutions to the CBI board and have our heart set on communicating as widely as possible on our assets and results.

We globally handle all transversal topics which help to set boundaries to production activities and to improve the production reliability.

We handle around 2 daily communications, 3 weekly reportings, 1 monthly reporting for the CBI management, 4 monthly business reports.

We also manage the CAB, WIP, DRP, ILSI activities with some oncall activities.

We are finally responsible for the CBI Run Portal.

Strong points:

Challenging mission which help to develop strictness, agile methods and precision in the communication

Ensures a good visibility from the management and all CBI colleagues

The collaboration with support & dev teams allow to develop IT and production knowledge

It a long running mission (stable for 3 years)/ Home working 2 days by week/ Human and contstructive context

Improvement axes :

Need to structure the information for all CBI team

Need to bring more and more visibility

Need to propose initiative to develop digital solutions and assets

Need to save workload by optimizing and automatizing RCT activities

Need to strengthen the way to perform in parallel run and project tasks

CBI colleagues and management expectations:

Be the point of contact on each run process to give advice on method and good practices

Ensure a strong proximity with support teams on daily basis to help on incident management, tickets data quality and to remind deadlines on incident reports and problem follow up. Bring visibility with reportings on production health and risk exposure, Sustain change preparation and prod stability.

Provide impact analysis and roadmap visibility and every transversal event (whenever it is a punctual operation, a WIP or a security exercise). Help to develop CBI production knowledge. Propose global action plan to secure the production and enhance its reliability

Expected level of knowledge and mindset:

- Good knowledge on ITIL processes and a 3 years’ experience in the IT (change management and CAB administration/ incident management/ resolution communication and coordination/ able to challenge an incident report/ Problem follow up/ Production risk analysis)

- Knowledge sharing minded (wiki + procedures + training + self-learning video)

- Good communication

- Will to understand the production need and to propose a suitable solution

- Dynamic mindset interested in clarifying situations (impact analysis, process and rules definition, roadmap with roles and responsibilities) for other people

- Be able to perform regular concise executive summaries

- be reactive

Techno:

- Jira + Service Now

- Full Office suite with an ability on iconography usage and pivot table

- SQL developer (simple and joined queries)

- PowerBI (data refresh, report generation and new indicators building).

Interested applicants, please email your resume to Shaun Quek Yew Meng

Email: [email protected]

CEI Reg No: R1660732

EA Licence No: 99C4599

OUR COMPANY

We, at RegASK are a high growth global RegTech company leveraging technology and global network of experts to revolutionize regulatory intelligence, serving the LifeSciences (MedTech, CROs, Pharma) and FMCG industries (Food, Personal Care). RegASK team is highly diverse with more than 10 nationalities across 3 continents, we are entrepreneurial and very agile, enjoying the benefits of working across industries and across the globe. We are currently recruiting highly motivated talents to expand its team and support its ambitious growth plans.

RegASK is an international, diverse and rewarding place to work. If you are a builder, highly autonomous in your working style, and eager to problem solve, we would love to hear from you.

RegASK is part of Sprim Global Investments portfolio, a group of 500+ people in 19 offices across 6 continents, finding solutions, discovering and implementing new ideas to deliver better health.

THE POSITION

Title: Quality Assurance (QA) Analyst

As a Quality Assurance (QA) Analyst, you will play a crucial role in the software development life cycle by thoroughly testing and validating software applications to ensure they meet the highest quality standards. Your attention to detail, analytical mindset, and passion for delivering flawless software will contribute to the success of our projects.

Key Responsibilities:

Test Planning:

• Collaborate with cross-functional teams to understand project requirements and specifications.
• Develop comprehensive test plans and test cases based on project documentation.
• Develop and track test metrics

Manual Testing:

• Execute manual testing procedures to identify software defects and inconsistencies.
• Conduct functional, regression, and user acceptance testing.
• Defect Reporting:
• Document and prioritize identified defects, working closely with the development team to ensure timely resolution.
• Provide clear and detailed bug reports.

Test Documentation:

• Maintain accurate and up-to-date test documentation, including test cases, test scripts, and test results.
• Contribute to the creation and maintenance of testing standards and best practices.

Collaboration:

• Work closely with developers, product managers, and other stakeholders to ensure effective communication and understanding of project requirements.

Requirements:

• Bachelor's degree in Computer Science, Computer Engineering, Information Technology or any other relevant discipline
• 3 to 5 years of experience in manual software testing.
• Experience in Agile, software development life cycle (SDLC) and testing methodologies.
• Proficiency in creating detailed, comprehensive, and well-structured test plans and test cases.
• Excellent analytical and problem-solving skills.
• Strong communication skills with the ability to articulate testing processes and findings.
• SQL & data analytics skills are essential
• Able to write/execute queries for Mongo and MySQL Databases

How to Apply:

If you are excited about this opportunity and believe you have the skills and qualifications to excel as our QA Analyst, please submit your resume for consideration.

We appreciate all applications, but only selected candidates will be contacted for an interview.

Thank you for considering joining the RegASK team. We look forward to reviewing your application!