Senior Quality Engineer — Medical Devices (Onsite Arden Hills)

Boston Scientific; Arden Hills (MN); On-site; USD 85,000 - 161,500; Full time

Job summary

Boston Scientific's Arden Hills operations seeks a Senior Quality Engineer to lead quality initiatives, drive compliance, and mentor teams across the product life cycle. This role focuses on process validation, risk management, CAPAs and data-driven improvement, partnering with manufacturing, engineering and suppliers to ensure products meet regulatory and customer expectations.

The successful candidate will provide technical leadership, apply rigorous quality systems, and escalate critical

Qualifications

• Bachelor's degree in engineering or higher preferred.
• Strong understanding of quality operations fundamentals and regulatory requirements.
• Experience in regulated manufacturing environments.
• Experience with product risk assessment.
• Experience performing root cause analysis and implementing corrective actions.
• Experience with CAPA, nonconforming events and failure investigations.
• Experience with validation engineering and process validation.
• Knowledge of QSR, ISO standards and medical device regulations.
• Experience reviewing data to establish specs and performance standards.
• Excellent communication and cross-functional collaboration skills.

Responsibilities

• Select appropriate problem-solving techniques and make sound engineering and QA recommendations.
• Read and interpret technical drawings, procedures and protocols.
• Exercise independent authority to disposition nonconforming product.
• Identify manufacturing defects and support CAPAs and root-cause analysis.
• Participate in customer complaint investigations.
• Support CAPAs and nonconforming events and investigations.
• Promote compliance with QSR, ISO standards and medical device regulations.
• Provide guidance to Quality Engineers and technicians.
• Collaborate with EH&S and cross-functional partners to improve processes.
• Support internal quality audits and audit readiness.

Skills

Quality engineering

Regulatory knowledge

CAPA

Root cause analysis

Process validation

Risk management

Data analysis

Cross-functional collaboration

Education

Bachelor's degree or higher in engineering

Job description

Boston Scientific's Arden Hills operations seeks a Senior Quality Engineer to lead quality initiatives, drive compliance, and mentor teams across the product life cycle. This role focuses on process validation, risk management, CAPAs and data-driven improvement, partnering with manufacturing, engineering and suppliers to ensure products meet regulatory and customer expectations.

The successful candidate will provide technical leadership, apply rigorous quality systems, and escalate critical