Senior Manager - QA

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.

Essential Duties

Overall responsibility for maintaining site compliance with the requirements of the Baxter Quality Management System (QMS).

Assure excellence in site implementation of the product development process. Responsible for on site training on product development, change control, nonconformance / CAPA processes and design best practices.

Establishing and maintaining site QMS certifications, as applicable. • Responsible for building and developing a quality team that are experts in design assurance practices and actively partner with R&D teams to assure a high quality product.

Collaborate with teams to provide strategy and guidance for meeting Baxter requirements and External Quality Standards as appropriate.

Organize and implement site support of Corporate audits and Notified Body regulatory inspections. • Participate in scheduled MRs, Approve and distribute (or assign a designee to distribute) Management Review minutes

Ensure the Operational Structure’s quality system requirements and GxP compliance status are established and effectively maintained per the applicable regulations •

Report on the performance of the Operational Structure’s quality system to QMR for review and

escalates as needed.

Qualifications :

Demonstrated compliance knowledge in the areas of medical device and drug product development, change control, CAPA, and risk management.

Strong verbal and written communication skills • Strong interpersonal/communication/influencing/negotiation skills required

Demonstrated leadership, teaming, and communication skills accomplishing sucess with large teams • Demonstrated business acumen : international experience.

Knowledge of FDA (21 CFR Part 210, 211, 820, 803, 806), ISO 13485, ISO 14971, IEC 60601, ICH, EMEA, and CFDA regulations and standards for medical devices and therapeutics.

Strong analytical and problems solving skills utilizing DMAIC tools, Six Sigma Engineering, ASQ or other certifications desirable.

BS Degree (engineering, science or pharmaceutical related discipline) with 15 + years of experience in medical device industry or MS Degree with 5 years of experience in medical device industry. • 5-7 years of leadership experience.

Prior engineering/quality engineering or project management experience with a pharmaceutical product and medical device product.

Demonstrated skill of managing larger team supporting New product initiative and sustanance project with good understating of Medical device lab enviorment.

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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