QUALITY ENGINEER

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.

1. Ensure Product Quality meets requirements: a) Review and improve manufacturing Quality operations, Quality trends of product (process & final) and maintain Product Quality thru re-training and CIAs. b) Identify improvement areas and recommendation of Quality improvement processes to manufacturing and liaise with Mfg/ Mat. personnel to reinforce GMP/ GDP requirements. 2. Equipment and Process Validation: a) Initiate studies to validate and evaluate equipment & processes (New) and monitoring of equipment and processes to identify areas for continuous improvements. b) Establish specifications, Quality acceptance criteria and Inspection methods for routine manufacturing operations. 3. Failure Analysis for Equipment, Process and Product: a) Identify root causes of problem and initiate corrective/ preventive actions and liaise with divisional staff on technical & Quality issues and review SOPs, specifications, changes for adequacy and Quality requirements. 4. Customer Complaints Handling and Feedback: a) Evaluation of customer complaints- internal feedback initiation and implement corrective/ preventive actions. 5. Introduction of New Products/ Changes: a) Communicate, co-ordinate, plan and execution of requirements during FOC run. Conduct stability study where applicable. 6. Product sterilization meets sterility requirements. Sterilization system management and maintenance activities meets specification requirements (Steam sterilization- Quality Engineer): a) Ensure sterilizers/ cycles qualifications are completed perrequirements and coordinate with Microbiologist/ chemists to perform required tests and monitoring activities. b) Review impact of product, equipment, process changes to sterilizer qualification status and changes to Vessel (EOM) and to ensure required tests and documentation are complete. c) Review sterilization process, coordinate with process owner to ensure compliance and participate and review sterilization exception and continuous improvement. d) Coordinate with Microbiologist/ chemists to perform required tests and monitoring activities and ensure equipment used for sterilization qualifications calibrated/ validated and maintained. 7. Managed assigned Projects: a) Plan, organise, execute and monitor projects. 8. Six Sigma Process Control: a) Evaluate, install and monitor SPC processes. 9. Responsible for compliance to EHS procedure and requirement.

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

Recruitment Fraud Notice

Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.