Hybrid: Lead Supplier Quality Engineer (Medical Devices)

Natus Medical Incorporated; Madison (WI); Hybrid; USD 90,000 - 100,000; Full time

Benefits offered by this job

Health benefits

401k contribution

Paid time off

Job summary

Natus Medical Incorporated in Middleton, WI (Hybrid Role) is seeking an experienced Supplier Quality Engineer to own supplier quality activities, audits, and continuous improvement. You will work with suppliers and internal teams to resolve issues, ensure compliance, and support new product introductions.

The role requires at least 5 years in quality or supplier quality within medical devices, ISO 13485 and FDA QSR knowledge, and willingness to travel to supplier sites across the US.

Qualifications

• Bachelor’s degree and at least 5 years of experience in Quality, Supplier Quality, or QA in the medical device industry or another regulated environment.
• Experience managing supplier qualifications, audits, nonconformance investigations, and corrective actions independently.
• Strong knowledge of ISO 13485, FDA quality system requirements, and applicable medical device regulations.
• Qualified ISO 13485 Lead Auditor with experience conducting supplier audits.
• Ability to travel to supplier locations within the US.

Responsibilities

• Own quality activities for assigned suppliers and ensure regulatory compliance.
• Qualify and assess suppliers to meet quality expectations.
• Monitor supplier performance and drive improvements.
• Lead supplier audits and manage SCARs and CAPAs.
• Collaborate with cross-functional teams to resolve supplier challenges.
• Support new product introductions and manufacturing changes.

Skills

Quality engineering

Supplier quality

Regulatory compliance

Problem solving

Communication

Travel willingness

Education

Bachelor’s degree

Tools

ISO 13485

FDA QSR

Job description

Natus Medical Incorporated in Middleton, WI (Hybrid Role) is seeking an experienced Supplier Quality Engineer to own supplier quality activities, audits, and continuous improvement. You will work with suppliers and internal teams to resolve issues, ensure compliance, and support new product introductions.

The role requires at least 5 years in quality or supplier quality within medical devices, ISO 13485 and FDA QSR knowledge, and willingness to travel to supplier sites across the US.