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.
Summary
Covering this position, you’ll have the opportunity to execute Product Quality activities within New Product Development (NPD), Sustaining Engineering (SPO) and Regulatory Compliance projects for chronic and acute blood sets disposables, based on the project assignments received by the Product Quality Manager/Supervisor.
You’ll also support the organization during quality Audits and participate directly to projects for continuous improvement of product quality of Vantive disposable devices.
What you’ll be doing
1. Be a member of Project Core teams for New Product Development Projects and design Change Controls as Product Quality representative.
2. Execute Product Quality activities within New Product Development (NPD), Sustaining Engineering (SPO) and Regulatory Compliance projects for chronic and acute blood sets disposables, based on the project assignments received by the Product Quality Manager/Supervisor.
3. Review the documents for Device History File issuing and maintenance as Product Quality approver.
4. Assure compliance to all applicable Company’s corporate procedures as well as all local work instructions and applicable laws and standards.
5. Ensure that performance data from current products in the field (complaints, NCR/CAPA, Field Actions) are considered in sustaining engineering activities.
6. Cooperate and support other Company entities for Audits (internal and external) preparation.
7. Periodically report to Product Quality Manager/Supervisor about the status of activities under his/her responsibility.
What you’ll bring
1. University Degree in Engineering, Biomedical or Life sciences (Chemistry, biology…)
2. At least 2-3 years of experience in medical devices or pharmaceutical industries, preferably in Research and Development, quality and/or regulatory positions.
3. Fluent English knowledge (written and oral)
4. Knowledge and experience of Quality System based on ISO 13485, FDA CFR, GMP regulation and MDSAP
5. Knowledge of Design Control and Risk Management principles
6. Preferred knowledge in quality engineering methods (e.g.: statistical techniques, Six Sigma, Root Cause Analysis, Pareto, etc.).
7. Critical thinking, problem-solving, collaboration, communications and negotiation skills are required
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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