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.
Quality Systems Manager
Responsibilities of the role:
- Adheres to all environmental, health and safety requirements, quality system procedures, and facility policies
- Leader in compliance to all necessary regulations
- Assesses conformance to documented procedures, regulatory, statutory, plant, divisional and corporate requirements
- Assists in the establishment and maintenance of the assessment process including scheduling, performing and generating audit reports
- Responsible for the management of the Internal Assessment Programme and the Documentation System
- Co-ordination of Audits by Regulatory Bodies and Contract Drug Companies
- Responsibility for the Supplier Quality Management programme which includes assessing and approving supplier quality systems, inspection of Suppliers for reduced inspection or certification
- Responsibility for ensuring that an effective quality system is in place and provides assistance to management in the development of quality management systems
- Responsibility for the management of the documentation, labelling and training departments. Responsible for the adherence to quality systems that involve the changes to procedures, labels and BOMs etc.
- Responsible for management of training in conjunction with area management for their respective areas.
- Responsible for the receiving and inspection and release of raw materials from 3rd party suppliers.
- Tracks the status of audit issues to help ensure that adequate actions are taken, documented and completed in a timely manner
- Maintains adequate documentation to demonstrate that assessments have been performed as scheduled
Experience requirements:
- Certification from a Recognized Body (preferred)
- Three to five years of related experience required (preferably quality auditing experience within a medical device or other regulated industry)
- Excellent communication and writing skills
- Excellent interpersonal skills
- Good presentation skills
- Reasoning Ability
- The ability to exercise independent judgment and draw accurate conclusions based on available information
Education requirements:
- Bachelor's degree or equivalent related experience
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
