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Manufacturing Engineer
2 months ago
The position of Manufacturing Line Quality Engineer is within our Infectious Disease Developed Markets business unit located in Westbrook, Maine. In this role, you will provide support for product quality assurance, process improvements, and all quality system programs at the Westbrook Site.
Key Responsibilities:
- Support production with the resolution of quality issues in accordance with established procedures.
- Provide on-the-floor support to the manufacturing team, ensuring adherence to procedures and appropriate Device History Record (DHR) documentation. Support line clearances, reworks, and inspections as required.
- Demonstrate commitment to the development, implementation, and effectiveness of the Quality Management System (QMS) per ISO, FDA, and other regulatory agencies.
- Exhibit professional behavior with both internal and external business associates that reflects positively on the company and aligns with the company’s policies and practices.
- Understand and be aware of the quality consequences that may result from improper job performance. Maintain awareness of potential device defects in their area of responsibility, including product design, verification and validation, manufacturing, and testing activities.
- Perform other duties as assigned, according to the changing needs of the business.
Basic Qualifications:
- Bachelor’s Degree in Engineering, Chemistry, Biotechnology, Life Science, or another technical field, or the equivalent combination of education and experience.
