Senior Quality Systems Engineer

Senior Quality Systems Engineer

This Senior Quality Systems Engineer role is responsible for owning and executing CAPA activities within the field action and quality systems processes to drive continuous improvement and close identified gaps. The individual will lead CAPAs end-to-end—from planning through execution and delivery—while collaborating cross-functionally with subject matter experts to identify root causes and implement effective solutions. This role requires a professional who can work within a matrix organization, coordinate across teams, and independently manage multiple quality system initiatives.

The position is designed to strengthen CAPA ownership and enhance overall quality system performance, with a focus on regulated environments and continuous improvement efforts.

Your responsibilities will include:

• Support site CAPA and NCEP activities as a SME, mentor and/or trainer
• Track and trend CAPA and NCEP related information and report at various review boards to a broad audience
• Champion quality and compliance to quality requirements throughout the NCEP and CAPA process
• Lead and/or support timely implementation of projects within the Arden Hills Quality Operations organization, including continuous improvement projects
• Work with Quality and other leaders to identify areas within NCEP/CAPA in need of improvement and lead such improvements
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to position responsibilities
• Contribute actively to internal BSC global Communities of Practice

Required qualifications:

• Bachelor's degree
• Minimum of 5 years of related experience in quality engineering or quality systems engineering within a regulated industry
• Demonstrated CAPA and Nonconforming Product (NCP) experience
• Proven ability to own and drive CAPAs end-to-end (planning, execution, and delivery)
• Strong problem-solving skills with the ability to identify root cause and implement solutions
• Proficiency with Microsoft Office Suite

Preferred qualifications:

• Experience in medical device industry
• Experience supporting field action / PIR processes or similar quality system improvement initiatives
• Demonstrated ability to drive continuous improvement efforts within quality systems
• Exposure to or experience with global or multi-site environments