Medical device manufacturing company is in immediate need of a Quality Specialist to assist in controlling and overseeing of manufacturing process to ensure that FDA and ISO regulations are met. The Quality Specialist will define product configuration to standards, develop a comprehensive filing system to retain and control all documents and to update and monitor company training database to ensure all employees have access to updated expectations and appropriate documentation, regarding FDA and ISO regulations. The Quality Specialist will also update SOP’s and work forms/instructions, help maintain all device records, generate reports when materials are defective, assist with audits, assist in sampling and inspecting raw materials and conduct product inspections.
Required Skills to Perform the Essential Functions:
• High school diploma/equivalent
• Experience with ISO 9001/ISO 13485 and/or FDA regulations preferred.
• Good understanding of Excel, Word, and Outlook.
• Understanding of eQMS and MRP software desired.
• Understanding of machining and assembly operations.
• Knowledge of standard inspection and test equipment (e.g. Calipers, Micrometers, Height gage)
• Able to work with a high volume of documents in a fast-paced environment.
• Follow safety and security practices and maintain confidentiality of information.
NOTE: Candidates that are offered a position are required to pass pre-employment drug and background screening. Qualified candidates with criminal histories, are considered in a manner that is consistent with local, state and federal laws.
Qualified candidates please email your resume email@example.com