CAPA & Quality Systems Lead

Regulatory Jobs; Golden Valley (MN); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Health insurance

401k with match

Tuition reimbursement

Employee assistance program

Job summary

Inspire Medical Systems seeks a CAPA and Quality Systems specialist to lead corrective and preventive action efforts across internal and supplier actions. You’ll partner with development, manufacturing, marketing and quality teams to ensure adherence to ISO 13485 and FDA quality system requirements, monitor CAPA timelines, and drive continual improvement.

Ideal candidates have 2–5 years in medical device quality or design, strong leadership, and proficiency with MS Word, Excel and PowerPoint.

Qualifications

• Bachelor’s degree in a technical or scientific field.
• Preferred engineering discipline (electrical, mechanical, materials, manufacturing or biomedical).
• 2–5 years minimum experience in quality or design in finished medical device industry.
• Knowledge of ISO and FDA/Quality System requirements.
• Strong project and time management skills; problem solving for compliance.

Responsibilities

• Manage CAPA process for internal Inspire CAPAs and supplier SCARs.
• Lead cross-functional teams to resolve quality issues and CAPA
• Monitor CAPA deliverables, timelines and trends for CAPAs/SCARs
• Schedule CAPA team meetings and monthly CAPA reviews
• Report CAPA progress at monthly meetings and quality reviews
• Support CAPA activity including root-cause analysis and verification
• Partner with product quality and manufacturing teams on supplier actions
• Provide audit support for CAPA and SCAR processes
• Collaborate with Material Quality to develop SCAR timelines
• Support non-conformance processes and process trending
• Assist in developing quality work instructions and updates

Skills

CAPA management

Quality systems

Regulatory compliance

Project leadership

MS Office

Problem solving

Education

Bachelor’s degree in technical or scientific field

Bachelor’s degree in engineering

Master’s degree in technical field

Tools

Quality management systems

Job description

Inspire Medical Systems seeks a CAPA and Quality Systems specialist to lead corrective and preventive action efforts across internal and supplier actions. You’ll partner with development, manufacturing, marketing and quality teams to ensure adherence to ISO 13485 and FDA quality system requirements, monitor CAPA timelines, and drive continual improvement.

Ideal candidates have 2–5 years in medical device quality or design, strong leadership, and proficiency with MS Word, Excel and PowerPoint.