The Role
Manage supplier quality for medical device components and services, including supplier qualification, performance monitoring, audits, nonconformance investigations, SCARs, corrective actions, and regulatory compliance. Collaborate with Engineering, Manufacturing, Sourcing, Regulatory Affairs, and Quality teams. Support new product introductions, product transfers, manufacturing changes, FDA and BSI inspections, supplier validations, and continuous improvement initiatives.
Summary Generated by Built In
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.
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 RoleWe'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 DoManage 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.
- 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).
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.
Be the People part of the Neuro Solution. Apply Today.
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.
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Skills Required
- Bachelor's degree
- At least 5 years of relevant experience in Quality Engineering, Supplier Quality, or Quality Assurance within the medical device industry or another regulated environment
- Experience managing supplier qualifications, audits, nonconformance investigations, and corrective actions independently
- Working knowledge of ISO 13485, FDA quality system requirements, and applicable medical device regulations
- Qualified ISO 13485 Lead Auditor with supplier audit experience
- Experience collaborating with Engineering, Manufacturing, Sourcing, and Quality teams
- Strong communication, organizational, and problem-solving skills
- Ability to work independently, manage competing priorities, and resolve issues
- Willingness and availability to travel to supplier locations within the United States
- Experience reviewing and approving supplier validation protocols, including IQ/OQ/PQ
- Experience with First Article Inspections
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The Company
What We Do
Natus Medical Incorporated (Natus) offers medical equipment, software, supplies and services for the diagnosis, monitoring, and treatment of impairments and disorders effecting the brain, neural pathways, and eight sensory nervous systems. Our comprehensive product portfolio represents a heritage of innovation and leadership. Natus brands have been setting the standard for patient care for over eighty (80) years. Our products are trusted by medical professionals in university medical centers, hospitals, private practices, clinics and research laboratories around the world.
