Senior Quality Engineer

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 Senior Quality Engineer is responsible for supporting and sustaining Medical Device Quality Technology and Engineering activities related to design control and post-market product support for therapeutics products.

• Prepare and manage the internal audit schedule for Vantive Twin Cities
• Assist in performing internal audits for the Medical Device R&D organizations as well as Drug Product R&D organizations
• Prepare internal communications related to the audit including final reports.
• Perform and host internal audits in conjunction with the Quality Manager
• Ensure site compliance with local and global Quality Management System Procedures.
• Perform quality-related functions for post market activities such as Nonconformance Investigation and Corrective and Preventive Action (CAPA) Management.
• Consult with site personnel as QMS Subject Matter Expert to advise on QMS requirements.
• Assist in preparing and hosting external audits with regulatory authorities.
• Review and approve design inputs, outputs, verifications, validations, and design transfers in accordance with QMS requirements.
• Assist in decision making for process and product improvement efforts.
• Write, review, analyze and revise Local QMS documentation.

• Bachelor’s Degree in related field and 3+ years of relevant experience in the medical device industry or similarly regulated industry. Or substitute 7 years of relevant experience in the medical device industry or similarly regulated industry.
• Minimum 2 years of experience performing internal or external audit activities.
• Demonstrate understanding in the areas of Quality Engineering and worldwide Quality System standards and regulations.
• Ability to work under deadlines and changing priorities with minimal supervision.
• Must be a team player with excellent verbal and written communication skills to work cross-functionally in a highly matrixed organizational environment.
• Strong analytical and problem-solving skills
• Demonstrated ability to perform within project and investigational environments.

• B.S. in Engineering or Science Discipline
• Formal Audit training or certification
• American Society for Quality Certification (e.g., CQE, CQA, etc.) and/or Six Sigma certification highly preferred.
• Demonstrated assertiveness and ability to represent the Quality function in various roles in support of R&D engineering activities including product support and lifecycle management.
• Experience / understanding of Risk Management techniques and principles.

Vantive is committed to supporting the need for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

We understand compensation is an important factor as you consider the next step in your career. At Vantive, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $80,000 to $100,000 annually. The estimated range is meant to reflect an anticipated salary range for the position.

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