Senior Quality Systems Engineer
Job in
Arden Hills, Ramsey County, Minnesota, USA
Listed on 2026-08-22
Listing for:
Boston Scientific Gruppe
Full Time
position Listed on 2026-08-22
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
About the role:
Senior Quality Systems Engineer 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 to strengthen CAPA ownership and enhance overall quality system performance, particularly in regulated environments.
Yourresponsibilities 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
- 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
- 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
Position Requirements
10+ Years
work experience
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