Manufacturing Engineer

Job Title: Manufacturing Engineer
Job Description
This Manufacturing Engineer role focuses on process and retrospective validations, quality-driven manufacturing support, and MDR remediation efforts within a regulated medical device environment. You will apply a strong ISO-based quality mindset, execute rigorous validation activities, and maintain high standards of documentation to ensure compliant, efficient, and continuously improving manufacturing processes.
Responsibilities

+ Execute process validations, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and retrospective validations for existing processes.

+ Support MDR remediation activities by reviewing, updating, and maintaining all related documentation to align with current regulatory expectations.

+ Perform statistical data analysis to support validation activities, assess process capability, and identify opportunities for continuous ...