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.
The Quality Associate is responsible for Product Quality for solutions & containers products. Provide quality guidance for the successful completion of new and improved product design and implementation projects within quality, time and budget.
Duties and Responsibilities:
- Work closely with product design owners and engineering to support NPD activities including Design & Development Plans, design inputs, outputs, verification, validation, and design transfer strategies according to the Product Development & Life Cycle Management (PDLM) process and based on the established Quality Plan, while maintaining necessary risk control measures.
- Provide support to sustaining engineering (fielded product) specifically through supporting risk and change control management execution.
- Provide support to Drug and Science team with protocol planning, execution and reports including support to assigned large programs.
- Provide post market surveillance support and data including complaint investigation, complaint trending and complaint rate of new / emerging issues reported from the field to support Event Based Risk Reviews, NCR / CAPA and FA, as necessary. Lead PQDR (Product Quality Data Reviews).
- Provide quality input to DHF and risk remediation activities.
- Manage activities of self and support others in achieving defined quality goals in an efficient, accurate and timely manner.
- Provide support to project personnel regarding the appropriate application of design, statistical and analytical tools.
- Support audit and compliance activities.
- Drive and champion the awareness and implementation of Vantive Quality policy and objective.
Education and experience required:
- University Degree in Engineering or Sciences(Pharmacy, Chemistry, Biochemistry)
- Minimum 2 years of experience in Quality, Manufacturing, Engineering in Medical Device or Pharmaceutical industry per EU and/or FDA requirements
- Medical Device regulatory experience preferred. (FDA, EU MDR, etc.).
- Knowledge of FDA (21 CFR Part 210, 211 & 820), ICH, and EMEA regulations (EU, GMP Part I & II) and ISO 13485 and 14971, MDR.
- Compliance knowledge in the areas of pharmaceutical product development, worldwide Quality System standards, laboratory control, change control, CAPA and risk management.
- Must be proficient with Microsoft Office and other data collection/analysis programs (e.g. Minitab, Excel).
What Vantive can offer to you:
- A permanent contract with a stable and secure work environment.
- A comprehensive benefits package, including private medical insurance, company pension scheme, and annual bonus scheme.
- A collaborative and dynamic work environment.
- Access to state-of-the-art equipment and technology.
- Recognition and reward for outstanding performance.
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
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