Senior Quality Engineer: Cardiac Diagnostics CAPA Leader

Socket.dev; Arden Hills (MN); On-site; USD 85,000 - 162,000; Full time

Job summary

Boston Scientific Corporation seeks a Senior Quality Engineer to provide critical quality engineering support for Cardiac Diagnostics. You will lead CAPAs, drive continuous improvement, and collaborate with cross‑functional teams to ensure regulatory compliance and patient safety.

The role involves problem solving, validation activities, and data-driven improvement of processes and products. Strong QA background in medical devices is required.

Qualifications

• Bachelor’s degree in engineering or related discipline.
• 5+ years of quality engineering experience (3+ years with a related master’s degree).
• Knowledge of Quality System Regulations, Medical Device Regulation, and ISO 13485.
• CAPA experience including leading root cause investigations and verification of effectiveness.
• Familiar with medical device risk management activities and related processes.
• Experience in Medical Device industry.

Responsibilities

• Apply systematic problem-solving methodologies to identify and resolve quality issues.
• Lead quality disciplines and participate in CAPA decisions.
• Organize and conduct investigational meetings with cross-functional teams and document CAPA activities.
• Evaluate adequacy and compliance of systems against regulations and documentation.
• Collaborate with technicians and engineers to disposition nonconforming material and identify root causes.
• Review and approve process validation and verification activities supporting corrective actions.
• Collect and analyze defect data for product/process improvements.

Skills

CAPA leadership

Problem solving

Analytical skills

Communication skills

Time management

Education

Bachelor’s degree in engineering

Master’s degree preferred

Tools

Windchill

MS Office

PLM

Job description

Boston Scientific Corporation seeks a Senior Quality Engineer to provide critical quality engineering support for Cardiac Diagnostics. You will lead CAPAs, drive continuous improvement, and collaborate with cross‑functional teams to ensure regulatory compliance and patient safety.

The role involves problem solving, validation activities, and data-driven improvement of processes and products. Strong QA background in medical devices is required.