Quality Engineer II

What you'll do

• Investigate nonconformances by identifying root causes and implementing corrective actions with cross-functional teams.
• Manage Corrective and Preventive Action (CAPA) activities including documentation, verification, and closure.
• Maintain compliance of calibration programs and support related quality activities.
• Execute and document process and equipment validation activities including IQ, OQ, and PQ.
• Develop and maintain quality documentation, procedures, and records to ensure regulatory compliance.
• Analyze quality data and trends to identify improvement opportunities and support risk-based decisions.
• Participate in internal audits, inspections, and regulatory readiness activities.

What we're looking for

• A Baccalaureate degree and minimum of 2 years of relevant experience or a Master's degree are required.
• Experience supporting quality system processes within a regulated manufacturing environment is required.
• Experience with nonconformance investigations, root cause analysis, and corrective action implementation is required.
• Working knowledge of quality documentation requirements and regulatory compliance standards is required.
• Ability to manage multiple projects while maintaining accurate and compliant documentation is required.
• Experience within the medical device industry is preferred.
• Working knowledge of TrackWise quality management systems is preferred.
• Work authorization at the time of hire and for the duration of employment.