Supplier Quality Engineer

Natus Medical Incorporated; Madison (WI); Hybride; USD 90 000 - 100 000; Plein temps

Avantages offerts par ce poste

Health benefits

401k contribution

Paid time off

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Quality engineering

Supplier quality

Regulatory compliance

Problem solving

Communication

Travel willingness

Formation

Bachelor’s degree

Outils

ISO 13485

FDA QSR

Description du poste

FOR MORE THAN 80 YEARS, Natus has been working in collaboration with clinicians to deliver industry-leading neuro solutions that help providers more easily make sense of the body’s signals.

Engineered with input from those who have lived the care experience, our technology simplifies complex processes and improves accuracy and efficiency. There is a role for everyone who wants to be part of the innovative solutions at Natus Neuro.

Location: Middleton, WI (Hybrid Role)

About the Role

We’re looking for an experienced Supplier 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.

Investigate Issues & Drive Solutions

• 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.

Lead Supplier Audits & Maintain Compliance

• 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 Projects & Continuous Improvement

• 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.

Nice to Have

• 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.

Be the People part of the Neuro Solution.

Pay Transparency:

Pursuant to the requirements of applicable State laws and regulations, the starting salary range for this position is $90-100K USD. Factors which may affect starting pay within this range may include geography/market, skills, education, experience and other qualifications of the successful candidate.

Compensation and Benefits:

Natus offers generous compensation and benefits packages including health benefits, 401k contribution, 7 paid holidays + 2 floating holidays of your choosing, generous paid time off, tuition reimbursement assistance program, eligibility for performance-based bonuses or commissions, where applicable and more.

EEO Statement:

Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.