Escalate issues to QA and/or Engineering Management if quality issues arise. Resolve quality related issues between the QA department and other departments.

Coordinate with engineers, technicians, and production or other department heads to ensure quality standards are maintained.

Ensure containment (identification, segregation, and reconciliation) of non-conforming product has been performed.

Participate in cross-functional team to investigate quality issues/problems, perform risk assessments, historical record review and disposition and correction/corrective action strategy for non-conformances.

Monitor and trend quality data to identify potential quality issues.  Provide trended quality data to Management.

Interpret and utilize Risk Management Files (Failure Modes and Effects Analysis).

Ensure compliance to the Quality Management System and may own corrective actions (CAPA).

Apply statistical methods to define sampling plans for Verification of Effectiveness.

Evaluate required changes to electronic Quality Management systems for continued compliance to external standards and regulations.  Assist in the implementation of new Quality modules in the electronic Quality Management system.

Support audit activities including supporting external audits and addressing audit findings

Bachelor’s degree in Engineering or related technical field.

Minimum 5 years of Quality Engineering experience.

English proficiency both written and verbal

General knowledge of 21 CFR 820, ISO 13485 and MDSAP