Senior Principal Quality Engineer

Begell House Inc.; Minnesota; On-site; USD 120,000 - 165,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) retirement plan

Paid time off 20–35 days

Parental leave

Education assistance

Commuting benefits

Job summary

Vantive in Oakdale, MN seeks a Senior Principal Quality Engineer to lead quality support for drug products and medical device R&D, ensuring QMS compliance and EU MDR alignment. On-site engagement with the R&D team and QA Manager is required.

The role demands GLP/GMP expertise, CAPA management, and cross-site QMS harmonization, with 6+ years in regulated labs and a strong quality engineering background.

Qualifications

• Bachelor's Degree in a related field and 6+ years in medical device/pharma or similarly regulated industry.
• Experience in analytical chemistry or microbiology labs supporting regulated products.
• Familiarity with GLP/GMP regulations and QMS.

Responsibilities

• Act as the primary Quality SME for drug product and medical devices at the on-site labs, aligning with QMS and EU MDR.
• Review and approve site QMS docs, protocols, reports, qualifications, and change controls.
• Support site readiness for audits, develop audit plans, and participate in internal and external audits.
• Perform CAPA and nonconformance investigations; ensure compliance across R&D activities.
• Harmonize QMS practices across R&D sites and provide training.

Skills

Quality engineering

Regulatory compliance

Communication skills

Analytical chemistry lab

Quality system standards

Education

Bachelor's degree in related field

Audit training or certification

Tools

EU GMP (EudraLex Vol 4)

ISO 13485

ISP guidelines

USP guidelines

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. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

US Benefits at Vantive

• 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.
• Flexible Spending Accounts
• educational assistance programs
• 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.
• commuting benefits
• the Employee Discount Program
• the Employee Assistance Program (EAP)
• childcare benefits.

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

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