Senior CAPA & Quality Systems Leader

Boston Scientific; Arden Hills (MN); On-site; USD 80,000 - 120,000; Full time

Job summary

Boston Scientific is seeking a Senior Quality Systems Engineer based in Arden Hills, Minnesota. The successful candidate will own and execute CAPA activities, collaborating across teams to drive quality improvement. Required qualifications include over 5 years in quality engineering and demonstrated CAPA experience.

The role involves mentoring, tracking CAPA initiatives, and supporting quality compliance. Preferred experience in the medical device industry and in quality system improvement is advantageous.

Qualifications

• 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.

Responsibilities

• 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.
• Champion quality and compliance to quality requirements throughout the NCEP and CAPA process.

Skills

Quality engineering

CAPA management

Problem-solving skills

Proficiency with Microsoft Office Suite

Job description

Boston Scientific is seeking a Senior Quality Systems Engineer based in Arden Hills, Minnesota. The successful candidate will own and execute CAPA activities, collaborating across teams to drive quality improvement. Required qualifications include over 5 years in quality engineering and demonstrated CAPA experience.

The role involves mentoring, tracking CAPA initiatives, and supporting quality compliance. Preferred experience in the medical device industry and in quality system improvement is advantageous.