Full-Time Quality Control Inspector
Job Description
Summary
Responsible for assuring that materials, activities, processes, and specified conditions related to the daily device manufacturing, processing and packaging meet current GMP standards and comply with applicable procedures and standards such as to ensure the quality integrity of the product.
Essential Functions
- Inspects raw material to meet production requirements and conducts in-process inspection of manufacturing product and processes. Assists in MRB activities. Assists in the Madison Manufacturing documentation control room.
- Completes documentation of activities performed, prepares and attaches material quality status labeling. Ensures storage and handling of product and labeling in a controlled and secure manner.
- Develop, implement and maintain QA procedures, standards and controls.
- Supports Quality through occasional conduct of investigations of nonconformance, assists with preventive actions associated with the QA unit.
- Performs quality reviews for quarantine releases on non-reportable, non-complaint, RMF-3 internal to a RSC.
Minimum Requirements
Education / Experience / Skills:
- High School diploma or equivalent
- One year experience in a regulated work environment preferred.
- Knowledge of FDA Quality System Regulations and ISO13485 pertaining to medical device manufacturing
Competencies:
- High Level of motivation; ability to work independently; strong attention to detail.
- Good interpersonal skills: ability to communicate well, both verbally and written
Organizational Relationship/Scope:
Reports to the Quality Control Manager. This position is accountable for delivery of the highest quality products according to defined forecast and schedule. Working across multiple functions, this
position collaborates primarily with manufacturing and quality to resolve product production related issues.
Working Conditions:
Manufacturing facility of medical devices and accessories. Controlled environmental working conditions.
How to Apply
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