Quality Engineer Job

Quality Engineer is needed to perform the following duties:

· Create and maintain quality documentation, including First Article Inspection (FAI) reports, specifications, and statistical quality control reports.

· Review and update SKUs, categorizing them into compliance groups based on manufacturability and quality standards.

· Develop clear documentation outlining vendor requirements, expectations, and quality standards to ensure supplier compliance.

· Support EU MDR remediation activities by reviewing DHFs, DMRs, and Technical Files to ensure compliance with ISO 13485 and ISO 14971.

· Coordinate with cross-functional teams to resolve nonconformances, implement CAPA, and drive continuous improvement

· Standardize quality processes across production stages to ensure consistency, manufacturability, and compliance.

Bachelor's Degree is required in Mechanical Engineering or Industrial Engineering or Engineering Management .

Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave