Quality Engineer
3 weeks ago
The position of Manufacturing Line Quality Engineer is within our Infectious Disease Developed Markets business unit. In this role you will provide support for product quality assurance, process improvements and all quality system program at the Westbrook Site.
This job description will be reviewed periodically and is subject to change by management.
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.
• 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.
- Open to HS Diploma or Associate's but Bachelor's is preferred
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
The purpose of this position is to initiate medical device quality assurance activities. These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards. This position will also support device complaint investigation and failure analysis as required. Essential Duties and Responsibilities: Develop incoming inspection processes and document incoming inspection activities. Provide in-process QA support to include inspection and document review. Complete final acceptance activities. Manage the sterilization process, including validations and product sterile loads. Track nonconforming material and lead Material Review Board (MRB) efforts. Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing. Lead complaint investigations on returned product. Manage corrective action and quality improvement activities. Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc. Assist in the performance of quality system internal auditing. Support quarterly management review meetings. Establish, monitor and evaluate quality system metrics.
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