QUALITY ENGINEER

Vantive; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

Vantive, a leader in vital organ therapy, is seeking a Quality Assurance Specialist to enhance product quality and manage projects. The role involves ensuring compliance with quality standards, validating processes, and addressing customer feedback. Join a mission-driven team dedicated to improving patient outcomes through innovative solutions.

Qualifications

• Experience in quality assurance processes and project management.
• Familiarity with Six Sigma methodologies.
• Ability to analyze and resolve equipment and process issues.

Responsibilities

• Ensure product quality meets requirements through continuous improvement.
• Coordinate and execute validation studies for equipment and processes.
• Handle customer complaints and implement corrective actions.

Skills

Quality Assurance

Project Management

Six Sigma

Problem Solving

Compliance

Job description

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Responsibilities:

1. Ensure Product Quality meets requirements:
   • Review and improve manufacturing Quality operations, Quality trends of product (process & final) and maintain Product Quality through re-training and Continuous Improvement Activities (CIAs).
   • Identify improvement areas and recommend Quality improvement processes to manufacturing and liaise with Manufacturing/Material personnel to reinforce GMP/GDP requirements.
2. Equipment and Process Validation:
   • Initiate studies to validate and evaluate equipment & processes (New) and monitor existing equipment and processes for continuous improvements.
   • Establish specifications, Quality acceptance criteria, and Inspection methods for routine manufacturing operations.
3. Failure Analysis for Equipment, Process, and Product:
   • Identify root causes of problems and initiate corrective/preventive actions. Review SOPs, specifications, and changes for adequacy and compliance.
4. Customer Complaints Handling and Feedback:
   • Evaluate customer complaints, initiate internal feedback, and implement corrective/preventive actions.
5. Introduction of New Products/Changes:
   • Coordinate, plan, and execute requirements during FOC runs. Conduct stability studies as applicable.
6. Product sterilization:
   • Ensure sterilizers/cycles qualifications are completed per requirements and coordinate with Microbiologists/Chemists for testing and monitoring.
   • Review impact of changes to sterilizer qualification status and ensure documentation is complete.
   • Participate in sterilization process reviews and continuous improvement activities.
7. Project Management:
   • Plan, organize, execute, and monitor assigned projects.
8. Six Sigma Process Control:
   • Evaluate, install, and monitor SPC processes.
9. Compliance:
   • Ensure adherence to EHS procedures and requirements.

Reasonable Accommodation

Vantive is committed to providing reasonable accommodations to individuals with disabilities. If you need an accommodation during the application or interview process, please click on the link here and provide your contact information.

Recruitment Fraud Notice

Vantive has identified incidents of employment scams involving fraudulent parties. Please review our Recruitment Fraud Notice to learn how to protect yourself.