Senior Principal Quality Engineer

About the 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.

Responsibilities

• 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.

Requirements

• 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.
• 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.

Pay

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.