Quality Engineer Jobs

About The Position

Requirements

• Bachelor's degree.
• 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 evaluate 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, delivering against agreed timelines.
• Contribute to a team culture built on accountability, collaboration, continuous improvement, and patient safety.