CAPA Quality Lead for Medical Devices

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

Benefits offered by this job

Health insurance

401k matching

Tuition reimbursement

Flexible time off

Job summary

Inspire Medical Systems seeks a Quality/ CAPA leader to drive corrective and preventive actions across internal and supplier processes. You will collaborate with Development, Manufacturing, Marketing and IT to ensure compliance with Inspire procedures and regulatory requirements.

The role emphasizes leading cross-functional teams, monitoring CAPA timelines, and delivering audits and improvements in a fast-growing medical device environment.

Qualifications

• Bachelor's degree in a technical or scientific field.
• Preferred: Bachelor's in engineering (electrical, mechanical, materials, manufacturing or biomedical).
• Master's degree in a technical or scientific field (preferred).
• 2–5 years minimum experience in quality or design function in the finished medical device industry.
• Demonstrated leadership skills and ability to prioritize, execute and report on projects.
• Knowledge of ISO and FDA/Quality System Requirements (e.g., ISO 13485; ISO 14969; FDA 21 CFR Part 820, 821, 822).
• Strong project and time management skills.
• Demonstrated problem solving and creative thinking for compliance solutions.
• Ability to handle multiple tasks with changing priorities.
• Proficient with MS Word, Excel and PowerPoint.

Responsibilities

• Manage CAPA process for internal CAPAs and supplier CAPAs (SCARs).
• Lead cross-functional teams to resolve quality issues and drive CAPA closures.
• Monitor CAPA deliverables, timelines and trend CAPAs and SCARs.
• Schedule CAPA meetings and monthly CAPA reviews.
• Report CAPA progress at monthly CAPA and Quality reviews.
• Support CAPA activity including root cause analysis and verification of effectiveness.
• Partner with product quality and manufacturing teams on supplier corrective actions.
• Provide audit support for CAPA and SCAR processes.
• Collaborate with Material Quality on SCAR timelines and monitors.
• Support non-conformance and process trending.
• Develop quality work instructions and procedural updates.

Skills

Leadership

Project management

Time management

Problem solving

Communication

Education

Bachelor's degree in technical/scientific field

Master's degree in technical/scientific field

Tools

MS Word

MS Excel

PowerPoint

Job description

Inspire Medical Systems seeks a Quality/ CAPA leader to drive corrective and preventive actions across internal and supplier processes. You will collaborate with Development, Manufacturing, Marketing and IT to ensure compliance with Inspire procedures and regulatory requirements.

The role emphasizes leading cross-functional teams, monitoring CAPA timelines, and delivering audits and improvements in a fast-growing medical device environment.