Manager I, Quality

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 and Responsibilities:

• Demonstrate quality assertiveness and be able to represent the Quality function in various roles such as product support and lifecycle management.
• Assist in decision making for process improvement efforts.
• Provide quality role in assisting with generating Design Plans, reviewing design inputs, outputs,

verification, validation and design transfer strategies.

• Ensures that activities within the Product Development elements are performed in a manner consistent with the Design and Development Plan, Change Plan and Quality Planning.
• Support Risk Management activities for sustaining engineering projects.
• Support post market activities such as complaint investigation, complaint trending, CAPA, and FA
• Support global manufacturing facilities and associated manufacturing and supplier changes.
• Preside as key quality participant in compliance audits and FDA/ministry of health (MOH) inquiries.
• Lead and Support global procedure implementations at site for laboratory process and Analytical Studies.
• Perform CAPA reviews and provide input to management reviews.
• Support Supplier quality activities and assist to maintain Approved Entity List for the Site.
• Support CRO OOL, OOS and insight to the ongoing studies and SCAR.
• Responsible for Quality Assurance of the Product Development and Lifecycle Management process.
• Responsible for the compliance and approval of PDLM records to Vantive procedures throughout the product lifecycle.
• Collaborate with regulatory affairs as needed to guide teams in meeting quality/regulatory requirements based on the regulatory plan/strategy or assessment. 
• Collaborate with teams to provide strategy and guidance for meeting Vantive Requirements and External Quality Standards as appropriate.

Qualifications:

• Good interpersonal/communication/influencing/negotiation skills.
• Good analytical and problem solving skills.
• Working knowledge of FDA Regulations.
• Demonstrated ability to lead others within small project or investigational environments.
• Good technical overview of medical device verification, validation and test automation.
• Good understanding of 21 CFR Part 820, ISO 13485, EU MDD / EU MDR.
• Broad working knowledge of Medical Device Software Development Lifecycle and IEC 62304.
• Good understanding of medical device manufacturing process.
• Good Understanding of requirements for Calibration and Qualification of Test & Measurement equipment in labs used for Verification and Validation.

Education and/or Experience:

BS engineering and 12 + years in related Quality or Engineering field in the medical products industry.

ASQ (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification highly preferred.

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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