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.

Your Role

The Senior Quality Engineer is responsible for supporting and sustaining Drug Products & Medical Device Research & Development activities related to design control and post-market product support for therapeutics products. This role is part of a team at Vantive that is building up capability and laboratories in Oakdale, MN.

What you'll be doing

• Act as the main Quality SME for the drug product related activities on site, working closely with the Quality Manager to establish local procedures in compliance with 21 CFR 211 and monitor compliance

• Review and approve verification and validation protocols and reports, equipment qualifications, studies, and procedures related to drug product R&D

• Assist with internal and external audits for the Drugs Products and Sciences R&D groups

• Perform quality-related functions for post market activities such as Nonconformance Investigation and Corrective and Preventive Action (CAPA) Management

Required Skills

• Bachelor's Degree in a related field and 3 or more years of relevant experience in the drug products or pharmaceutical industry or a similarly regulated industry. Or in lieu of a Bachelor's Degree, 7 years of relevant experience in the drug products or pharmaceutical industry or similarly regulated industry.

• 3 or more years of experience working in and/or supporting an analytical chemistry lab in support of drug products R&D

• Must have familiarity with standard laboratory procedures and requirements

• Demonstrated understanding in the areas of Quality Engineering and worldwide Quality System standards and regulations

Preferred Skills

• B.S. in Engineering or a Science discipline

• Formal Audit training or certification

• American Society for Quality Certification (e.g., CQE, CQA, etc.) and/or Six Sigma certification highly preferred

• Experience with 21 CFR 211 GM highly preferred

• 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

• Ability to work under deadlines and changing priorities with minimal supervision

• 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

Vantive is committed to supporting the needs 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 $110,000 annually. The estimated range is meant to reflect an anticipated salary range for the position.

We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location,…