Quality Assurance Engineer

Role Description

The Quality Assurance Engineer is a full-time, on-site role based in Morgantown, PA. Under the supervision of the Quality Director, the Quality Engineer is responsible for keeping continual improvement of Quality Management Systems (QMS), ensure compliance with ISO 13485:2016 and 21 CFR 820, to secure all finished products and Azer Scientific processes are managed according to Customer requirements, Internal Procedures and regulations.

The engineer will participate in reviews of requirements and specifications, contribute to process improvements for QA workflows, and help maintain testing standards and best practices. The role involves working closely with cross-functional teams to support timely releases and continuous quality improvements.

Responsibilities

• Manage customer complaints, creating cases/tickets and communicate with customers to provide post-delivery support.
• Provide support for deviation, investigations, including root cause analysis, and corrective & preventive action (CAPAs)
• Initiate and lead actions to prevent the occurrence of nonconformities relating to product, process, and QMS.
• Manage Process validation, tests, controls, document and perform improvements, as needed.
• Manage calibration process of internal devices
• Create, review, and implement processes, procedures and other documentation including SOPs, Work Instructions & forms.
• Participate on New product design process and be able to discuss / update Product specifications and raw materials
• Support on vendor qualification process, eventually perform vendor audits, and prepare quality reports.
• Create Nonconforming reports for vendor issues and communicate with vendors to request corrective actions.
• Follow and improve relevant Quality Management System procedures to ensure manufactured products meet requirements.
• Coordinate employee training & maintain records related to the QMS
• Perform other duties as assigned.

Skills

• Strong knowledge of quality standards [cGMP, FMEA and respective controls preferred]
• Ability to make considered decisions and communicate them effectively.
• Strong leadership, time-management, and organizational skills
• Good numerical skills and an understanding of statistics
• MS Office: Excel, Word, Visio, Adobe Acrobat

Education

• Bachelor's degree in Engineering, or 3-5 years of equivalent experience
• Certified Quality Auditor (CQA), recommended
• Risk assessment management based on ISO 14791:2019, preferred
• Six Sigma certification, preferred