Supplier Quality Engineer

Natus•Madison, WI

1d•$90,000 - $100,000•Hybrid

About The Position

Natus is hiring an experienced Supplier Quality Engineer to ensure the quality and reliability of the parts, materials, and services used in its products. The role owns supplier quality activities, partners directly with suppliers and internal teams to resolve quality issues, improve supplier performance, and maintain compliance with regulatory requirements. Work includes supplier qualification and audits, investigation of complex quality issues, and support for new product introductions, product transfers, and manufacturing changes. The position is based in Middleton, Wisconsin, and is hybrid.

Requirements

Bachelor's degree and a minimum of 5 years of relevant experience in Quality Engineering, Supplier Quality, or Quality Assurance within the medical device industry or another regulated environment.
Demonstrated experience independently managing supplier qualifications, audits, nonconformance investigations, and corrective actions.
Strong working knowledge of ISO 13485, FDA quality system requirements, and applicable medical device regulations.
Qualified ISO 13485 Lead Auditor with experience conducting supplier audits.
Experience collaborating with Engineering, Manufacturing, Sourcing, and Quality teams.
Strong communication, organizational, and problem-solving skills.
Ability to work independently, manage competing priorities, and follow issues through to resolution.
Willingness and availability to travel to supplier locations within the US.

Nice To Haves

Experience reviewing and approving supplier validation protocols (IQ/OQ/PQ).
Experience with First Article Inspections (FAI).

Responsibilities

Own quality activities for an assigned portfolio of suppliers and ensure compliance with Natus requirements and applicable regulatory standards.
Qualify and assess suppliers against established quality expectations.
Monitor supplier performance, identify trends, and work with suppliers to drive improvements.
Review supplier change notifications and assess potential quality impacts.
Lead investigations into supplier-related nonconformances and manage Supplier Corrective Action Requests (SCARs) through resolution.
Work with suppliers to identify root causes, implement corrective actions, and address recurring quality issues.
Collaborate with Manufacturing, Engineering, Sourcing, Regulatory Affairs, and other teams to resolve supplier challenges and support business needs.
Plan, schedule, and conduct supplier quality audits to assess compliance with applicable quality and regulatory requirements.
Prepare audit reports, communicate findings, and work with suppliers to ensure timely closure of identified issues.
Support regulatory inspections, including FDA and BSI inspections.
Support supplier quality activities for new product introductions, product transfers, and manufacturing changes.
Identify opportunities to improve supplier quality processes and performance.
Independently manage assigned activities and projects and deliver against agreed timelines.
Contribute to a team culture of accountability, collaboration, continuous improvement, and patient safety.