Manufacturing Line Quality Assurance Specialist

4 weeks ago


Scarborough, Maine, United States Spectraforce Technologies Inc Full time

Job Title: Quality Engineer

Job Summary:
We are seeking a Quality Engineer to join our team at Spectraforce Technologies Inc. The successful candidate will provide support for product quality assurance, process improvements, and all quality system programs within our Infectious Disease Developed Markets business unit located in Westbrook, Maine.

Responsibilities:
Support production with resolution of quality issues in accordance with established procedures.
Support production on the manufacturing floor, ensuring adherence to procedures and ensure 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 occur 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.

Qualifications:
Bachelor's Degree in Engineering, Chemistry, Biotechnology, Life Science, or other technical field or the equivalent combination of education and experience.

Competencies:
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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