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Collabera

Collabera is looking for a Manufacturing Engineer  #EngineerJobs #ManufacturingJobs

Job Description The position of Manufacturing Line Quality is within our Infectious Disease Developed Markets business unit located at Westbrook, Maine. In this role you will provide support for product quality assurance, process improvements and all quality system program at the Westbrook Site. 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. ? Support the NC and CAPA processes by completing risk assessments, root cause investigations, and action plans. ? Reviews qualifications, validations, and other studies for technical content, statistical and sampling rationale, unintended impact and clarity. ? May participate on design transfer and improvement project teams. ? 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 companys 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. ? Other duties as assigned, according to the changing needs of the business. BASIC QUALIFICATIONS | EDUCATION: ? Bachelor’s Degree in Engineering, Chemistry, Biotechnology, Life Science or other technical field or the equivalent combination of education and experience. ? Knowledge of Agile program. ? Working knowledge of Database software; Internet 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 PREFERRED QUALIFICATIONS: ? P1: 1+ years experience in the medical device or other regulated industry. ? P2: 2-5 years experience in the medical device or other regulated industry. ? P3: 2-5 years experience in the medical device or other regulated industry. ? Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) Certification Job Requirements Word, Documentation, Engineering, Evaluation

Collabera

Tagged as: Engineer, Manufacturing

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