Fellow Quality Systems Engineer

Job Overview

As a Fellow Quality Systems Engineer at Boston Scientific, you will lead the global development and maintenance of quality assurance policies, procedures, and controls, ensuring compliance with industry standards and regulations. This hybrid role can be based at any of our production sites.

• Lead the PAAC sub‑process development and maintenance of process metrics and methods for performance improvement.
• Drive continuous improvement through the Quality System Steward and Community of Practice model.
• Implement training and develop technical tools to support a preventive quality culture.
• Assess changes to standards and regulations for impact on production and process control processes and initiate projects as needed.
• Lead or oversee major quality projects and provide input to the overall project portfolio.
• Facilitate external audits and provide support for global procedures.
• Deliver process improvements through the VIP model with year‑over‑year savings goals.
• Own CAPA activities necessary to improve global processes.

• Bachelor’s degree (minimum).
• 10+ years experience in medical device quality systems, production, or process control (or equivalent).
• Knowledge of medical device regulations and standards such as ISO 13485, 21 CFR 820, EU MDR.

• Advanced degree preferred.
• Understanding of ISO 14971, ISO 11607, 21 CFR 210/211, etc.
• Experience with enterprise control systems (e.g., Siemens MES, Windchill PDMS).
• Excellent interpersonal and presentation skills.
• Demonstrated inclusive leadership and strong analytical skills.

Arden Hills, MN;
Maple Grove, MN;
Spencer, IN;
Galway, Ireland;
Cork, Ireland;
Clonmel, Ireland;
Coyol, Costa Rica;
Heredia, Costa Rica.

Requisition
Minimum Salary: $122,100
Maximum Salary: $232,000

Boston Scientific is an equal opportunity employer. Compensation is commensurate with experience. Benefits are location‑dependent and available to eligible employees.