Senior Principal Quality Engineer

Begell House Inc.; Oakdale (MN); Hybrid; USD 120,000 - 165,000; Full time

Job summary

Vantive, a leader in vital organ therapy, is seeking a Senior Principal Quality Engineer to lead quality support for Drug Products & Medical Device R&D. The role focuses on laboratories, QMS documents, and regulatory compliance, located onsite in Oakdale, MN with regular on-site presence.

You will review and govern QMS documentation, support audits, and drive CAPA and nonconformance activities across multiple R&D teams, ensuring compliance with GLP/GMP and EU GMP requirements.

Qualifications

• Bachelor's Degree in a related field and 6+ years of experience in a regulated industry such as medical devices/pharmaceuticals.
• Familiarity with GLP/GMP regulations and worldwide Quality System standards.
• Ability to promote compliance to the QMS as the site Quality representative.
• Experience reviewing and approving QMS documentation and change controls.

Responsibilities

• Act as the primary Quality SME for drug product and medical devices activities at the on-site laboratories.
• Review and approve site generated QMS documentation (verification/validation protocols, reports, equipment qualifications, training plans, CAPA).
• Support site readiness for audits and participate in internal and external audits (EU GMP).
• Perform quality-related functions including Nonconformance Investigations and CAPA management.
• Harmonize QMS laboratory practices and training across R&D sites.

Skills

Quality engineering

GLP/GMP knowledge

Audit readiness

Education

Bachelor's degree in related field

Engineering or science degree

Job description

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 Principal Quality Engineer is responsible for leading quality support and sustaining activities for Drug Products & Medical Device Research & Development activities related to laboratory testing, product validations, and QMS documents management in support of therapeutics products. This role is part of a team of approximately 50 scientists and engineers in Vantive that is building up capability and laboratories in Oakdale, MN, and will be located onsite at least 3 days per week with the team.

What you’ll be doing:

• Act as the primary Quality Subject Matter Expert (SME) for drug product and medical devices related activities at the on-site laboratories, working closely with the Quality Manager and the local R&D team to establish local procedures in compliance with international regulations such as EU MDR, as well as the monitoring of local compliance to the Vantive Quality Management System (QMS).

• Review and approve site generated QMS documentation, including but not limited to verification and validation protocols and reports, equipment qualifications, studies, procedures, training plans, change control activities, laboratory investigations, equipment out of tolerance and other quality documentation related to local drug product and medical device R&D activities.

• Support site readiness for and participate in audit activities for the Drugs Products and Sciences R&D groups by developing audit plans, executing internal audits along with Quality Manager, and acting as a Quality SME for external audits, such as those for EU GMP regulation.

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

• Work with other R&D sites to harmonize QMS related laboratory practices and procedures, as well as applicable training.

What you’ll bring:

Required Skills

• Bachelor's Degree in a related field and 6+ years of relevant experience in the medical device or pharmaceutical industry or a similarly regulated industry. 5+ years of experience working in and/or supporting an analytical chemistry or microbiology lab in support of regulated products, such drug products.

• Ability and willingness to work independently, communicate effectively, make decisions, and promote compliance to company QMS as a Quality representative for the site.

• Must have familiarity with standard laboratory procedures and requirements under GLP/GMP regulations.

• Demonstrated understanding in general principles of Quality Engineering and worldwide Quality System standards and regulations.

Preferred Skills

• Experience with EU GMP (EudraLex Vol 4.) and ISO 13485 highly preferred

• Experience with ISP and USP Guidelines and Standards highly preferred

• Bachelor’s degree 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 / 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

• Understanding of scientific method and application of science to test method development and validation highly preferred.

• Ability to multitask, working on multiple projects and work activities running in parallel.

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 $120,000 to $165,000 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, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

US Benefits at Vantive

This is where your well-being matters. Vantive offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical, dental and vision coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Aon Pooled Employer Plan (“Aon PEP”), Vantive’s 401(k) retirement savings plan, to help you prepare for your future. The Aon PEP is designed to help improve retirement outcomes by providing retirement resources more efficiently. The plan offers a robust set of investment options, financial education, and a suite of resources to support your retirement goals.

We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Vantive’s US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Vantive

Equal Employment Opportunity

Vantive is an equal opportunity employer. Vantive evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Know Your Rights: Workplace Discrimination is Illegal