Overview

Evaluate product assembly to company quality standards

Responsibilities

• Understands and adhere to requirements related to Cleanroom standards
• Attention to detail related to written specifications and manufacturing instructions to assemble a variety of medical devices
• Work closely with other employees and supporting departments to address nonconformities relate to documentations within the Manufacturing Instructions of the product.
• Perform cGDP (Current Good Documentation Practice) review of completed Manufacturing Instructions
• Release Production MIs to the production floor in the Inventory Management database
• Perform receipt transactions of completed MIs
• Perform closure of lots in the Inventory Management database
• Perform closure of Time and Labor closure of completed lots
• Responsible for resolving GDP issues with Document Control and the Quality Departments when required
• Responsible for training Direct Labor on adherence to cGDP and GMPs (Good Manufacturing Processes).

Qualifications

• High school diploma or equivalent required
• Ability to read and interpret standard operating procedures and manufacturing instructions
• Prior Medical device assembly experience or working with small parts is a plus
• Candidate should have good eyesight, hand dexterity (hand coordination) and attention to detail
• Able to sit / gown for extended periods during the shift
• Able to work in an environment with low and occasionally increase background noise
• Experience with a quality background is a plus
• Experience with Med Device inventory management and transactions is a plus
• Prior experience using software to process transactions required.

Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.