Associate Manufacturing Line Quality Engineer

• Support production with resolution of quality issues in accordance with established procedures.

• Support production on the manufacturing floor, ensuring adherence to procedures and ensuring appropriate device history record (DHR) documentation. Supports line clearances, reworks, and inspections as required.

• Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.

• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

• Understands and is aware of the quality consequences which may result from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.

• Other duties as assigned, according to the changing needs of the business.

• Bachelor’s Degree in Engineering, Chemistry, Biotechnology, Life Science or other technical field or the equivalent Combination of education and experience.

• Working knowledge of Database software; Internet software; Inventory software; Spreadsheet software and Word Processing software.

• Working knowledge of FDA, cGMPs/QSR and ISO quality system requirements

• Strong technical writing skills and effective communication skills.

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