NM
Supplier Quality Engineer
Natus Medical
- 🇺🇸 United States
- Hybrid
- Mid level
- 23 hours ago
23 hours ago
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Location: Middleton, WI (Hybrid Role)
About the Role
We're looking for an experiencedSupplier Quality Engineer to help ensure the quality and reliability of the parts, materials, and services that go into our products.In this role, you'll take ownership of supplier quality activities, working directly with suppliers and internal teams to resolve quality issues, improve supplier performance, and maintain compliance with regulatory requirements.You'll be involved in everything from supplier qualification and audits to investigating complex quality issues and supporting new product introductions. This is an opportunity for someone who enjoys problem-solving, working across different teams, and taking responsibility for driving quality improvements.What You'll Do
Manage Supplier Quality & Performance- Take ownership of quality activities for an assigned portfolio of suppliers, ensuring compliance with Natus requirements and applicable regulatory standards.
- Qualify and assess suppliers to ensure they meet established quality expectations.
- Monitor supplier performance, identify trends, and work with suppliers to drive improvements.
- Review and assess supplier change notifications to evaluate potential quality impacts.
- Lead investigations into supplier-related nonconformances and manage Supplier Corrective Action Requests (SCARs) through resolution.
- Work closely 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 related to new product introductions, product transfers, and manufacturing changes.
- Identify opportunities to improve supplier quality processes and performance.
- Independently manage assigned activities and projects, delivering against agreed timelines.
- Contribute to a team culture built on accountability, collaboration, continuous improvement, and patient safety.
What We're Looking For
We're looking for someone with solid supplier quality experience who is comfortable managing their own priorities, working directly with suppliers, and navigating quality challenges in a regulated environment.Required Experience & Qualifications- 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.
- Experience reviewing and approving supplier validation protocols (IQ/OQ/PQ).
- Experience with First Article Inspections (FAI).
Interested in Joining Natus?
If you have experience in supplier quality, enjoy working through complex quality challenges, and want to contribute to maintaining high standards in medical device manufacturing, we'd like to hear from you.Â
Supplier Quality Engineer · Natus Medical