Senior Quality Engineer - Global Post-Market Excellence

Boston Scientific; Arden Hills (MN); Hybrid; USD 85,000 - 162,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Boston Scientific is seeking a Senior Quality Engineer to support global post-market complaint handling and regulatory compliance. You will establish robust process controls, apply SPC, and drive continuous improvement from intake to reporting.

Lead root cause investigations, develop CAPAs, and collaborate with Quality, Regulatory and IT teams to maintain SOPs and control plans in a hybrid work environment.

Qualifications

• Bachelor’s degree in industrial engineering, statistics or a related technical field.
• 5+ years of quality control experience in a regulated industry.
• Experience with SPC and quality data analysis.
• Knowledge of medical device regulations (ISO 13485, EU MDR) is favorable.

Responsibilities

• Establish robust process controls for complaint handling outputs.
• Lead CAPA investigations and implement preventive actions.
• Collaborate with cross-functional teams to ensure regulatory compliance.
• Document SOPs and control plans for consistency.

Skills

QC experience

SPC

Cross-functional collaboration

Statistical analysis

Root cause analysis

Education

Bachelor's degree in industrial engineering, statistics or a related technical field

Job description

Boston Scientific is seeking a Senior Quality Engineer to support global post-market complaint handling and regulatory compliance. You will establish robust process controls, apply SPC, and drive continuous improvement from intake to reporting.

Lead root cause investigations, develop CAPAs, and collaborate with Quality, Regulatory and IT teams to maintain SOPs and control plans in a hybrid work environment.