CAPA Program Lead — Medical Device Quality

Inspire Medical Systems, Inc.; Minneapolis (MN); Hybrid; USD 70,000 - 90,000; Full time

Benefits offered by this job

401k matching

Flexible time off

Tuition reimbursement

Employee stock purchase program (ESPP)

Equity awards

Job summary

Inspire Medical Systems is seeking a Quality/ CAPA leader to drive corrective and preventive actions across internal teams and supplier relationships. You will ensure CAPA progress, effectiveness verification, and regulatory compliance within the quality system.

The role requires collaboration with Development, Manufacturing, Marketing and Information Systems to align with Inspire procedures and regional regulations. A strong background in ISO 13485 and FDA quality requirements is essential.

Qualifications

• Bachelor’s degree in a technical or scientific field.
• Bachelor’s degree in engineering discipline (electrical, mechanical, materials, manufacturing or biomedical).
• Master’s degree in a technical or scientific field.

Responsibilities

• Lead CAPA and SCAR activities and monitor timelines.
• Coach cross-functional teams to resolve quality issues.
• Support CAPA closure with root-cause analysis methods.
• Partner with product quality and manufacturing to support supplier actions.
• Provide audit support for CAPA and SCAR processes.
• Develop quality work instructions and procedures.

Skills

Team leadership

Project management

Time management

MS Word/Excel/PowerPoint

Education

Bachelor’s degree in technical/scientific field

Bachelor’s degree in engineering (electrical/mechanical/materials/manufacturing/biomedical)

Master’s degree in technical/scientific field

Tools

ISO 13485 knowledge

FDA quality system requirements

dfMEA/pFMEA

Risk management ISO14971

Job description

Inspire Medical Systems is seeking a Quality/ CAPA leader to drive corrective and preventive actions across internal teams and supplier relationships. You will ensure CAPA progress, effectiveness verification, and regulatory compliance within the quality system.

The role requires collaboration with Development, Manufacturing, Marketing and Information Systems to align with Inspire procedures and regional regulations. A strong background in ISO 13485 and FDA quality requirements is essential.