Sr Eng, Quality Assurance, Programmatic

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.

Job Summary
Under direction of supervisor, responsible for supporting new product development and sustaining Quality Engineering activities related to medical device hardware.

Essential Duties And Responsibilities

• Demonstrate quality assertiveness and can represent the Quality function in various roles such as product support and lifecycle management.
• Provide quality role in assisting with generating Design Plans, reviewing design inputs, outputs, verification, validation and design transfer and deployment strategies for the digital platforms.
• Very good understanding of Software Development Lifecycle management and Agile methodologies.
• Support Risk Management activities for sustaining engineering projects.
• Support post market activities such as complaint investigation, complaint trending, CAPA, and FCA processes
• Assist in decision making for process improvement efforts
• Support global Renal manufacturing facilities and associated manufacturing and supplier changes
• Preside as key quality participant in compliance audits and FDA/ministry of health (MOH) inquiries

Qualifications

• BS engineering (Mechanical or Electrical engineering preferred) and 4-10 years in related Quality or Engineering field in the medical products industry.
• Broad working knowledge of Medical Device Software Development Lifecycle and IEC 62304
• ASQ (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification highly preferred Strong interpersonal/communication/influencing/negotiation skills.
• Strong 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 and validation
• Good understanding of FDA QSR Part 820, ISO 13485, EU MDD / EU MDR
• Basic 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.

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

Recruitment Fraud Notice
Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.