Hybrid Principal Quality Engineer - CAPA & Risk SME

Boston Scientific; Maple Grove (MN); Ibrido; USD 102.000 - 194.000; Tempo pieno

Descrizione del lavoro

Boston Scientific is seeking a Principal Quality Engineer for a hybrid role based in Maple Grove, MN, focusing on quality systems across development, manufacturing and post-market activities. You will apply ISO 14971 risk principles and drive CAPA programs with cross-functional teams to improve product quality and compliance.

The role requires strong collaboration, mentoring, and hands-on leadership to advance quality initiatives and support regulatory requirements.

Competenze

• Bachelor's degree in engineering, science, health sciences or related field.
• Experience with quality systems and controlled processes in regulated industries.
• Experience coordinating or managing CAPAs and quality investigations, including design changes.

Mansioni

• Apply advanced quality engineering principles to products, processes and sites to meet quality and regulatory requirements.
• Lead or mentor quality teams and cross-functional partners on quality processes and CAPAs.
• Develop and implement design controls, risk management, FMEAs and post-market activities as needed.
• Improve quality assurance processes, CAPA systems and problem-solving methods across the organization.

Conoscenze

Quality systems knowledge

CAPA management

Cross-functional collaboration

Mentoring

Formazione

Bachelor's degree in engineering, science, health sciences or related field

Descrizione del lavoro

Boston Scientific is seeking a Principal Quality Engineer for a hybrid role based in Maple Grove, MN, focusing on quality systems across development, manufacturing and post-market activities. You will apply ISO 14971 risk principles and drive CAPA programs with cross-functional teams to improve product quality and compliance.

The role requires strong collaboration, mentoring, and hands-on leadership to advance quality initiatives and support regulatory requirements.