Senior Principal Quality Engineer, Drug & Medical Devices

Vantive; Saint Paul (MN); On-site; USD 120,000 - 165,000; Full time

Benefits offered by this job

Health insurance

Dental coverage

Vision coverage

Life insurance

Disability insurance

401(k) retirement plan

Flexible spending accounts

Paid holidays

Paid time off 20–35 days

Parental leave

Commuting benefits

Employee discount program

EAP

Childcare benefits

Job summary

Vantive is a vital organ therapy company focused on extending lives through digital solutions and advanced services. The Senior Principal Quality Engineer will lead quality support for Drug Products & Medical Device R&D at onsite laboratories in Oakdale, MN, working with QA, R&D and global teams to ensure compliance and quality systems alignment.

Based in Minnesota, this role requires 6+ years in regulated labs, GLP/GMP familiarity, and strong project leadership to drive audits, CAPA, and QMS

Qualifications

• Bachelor's degree in a related field, 6+ years in regulated labs.
• Experience in analytical chemistry or microbiology labs for regulated products.
• Familiarity with GLP/GMP regulations and QA concepts.
• Understanding of global Quality System standards and regulations.

Responsibilities

• Act as the primary Quality SME for drug product and medical devices at on-site labs.
• Review and approve site QMS documentation, protocols, reports and change controls.
• Support audit readiness and participate in internal/external audits, incl. EU GMP.
• Perform CAPA and nonconformance investigations and related quality activities.
• Collaborate with other R&D sites to harmonize QMS practices and training.

Skills

Quality Engineering

GLP/GMP familiarity

Audit readiness

Problem solving

Effective communication

Education

Bachelor's degree in engineering or science

6+ years in regulated lab environment

Job description

Vantive is a vital organ therapy company focused on extending lives through digital solutions and advanced services. The Senior Principal Quality Engineer will lead quality support for Drug Products & Medical Device R&D at onsite laboratories in Oakdale, MN, working with QA, R&D and global teams to ensure compliance and quality systems alignment.

Based in Minnesota, this role requires 6+ years in regulated labs, GLP/GMP familiarity, and strong project leadership to drive audits, CAPA, and QMS