Job Description

Job Title:  Quality Associate

Pay:  $30.00 - $34.00/hour

Job Description:  This position supports a wide array of activities related to: NCR/CAPA and Training.  

• Execute Investigations, Root Cause Analysis, Correction, Corrective and Preventive Action activities in accordance with the Quality System Corrective/Preventive actions and product non-conformance control including: capturing data and investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting.
• NCRs and CAPAs including: capturing data and investigations associated with product deviations, product nonconformance's, CAPAs, scrap, and rework, and analyzing the data for the reasons of Quality Improvement and reporting.
• Support Change Control activities - Originate and review internal operating procedures and specifications through the Document Change process.
• Adherence to regulations - Assist with adherence to all Federal, State, and Local Regulations controlling the manufacture of medical devices.
• Support the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards.
• Originate, review, and approve internal operating procedures and specifications through the Document Change process

Requirements:

• BS/BA in Physical Science or Engineering.
• 3 - 5 years of experience working within a Quality department.
• 1 - 2 years of Validation experience.
• Experience in Quality Assurance and/or other regulated industry or similar experience a plus.
• Strong technical writing skills and general problem solving skills.
• Manage multiple priorities and work with interruptions.
• GLP and/or GMP experience a plus. 
• Requires Vision Assessment (20/20 near visual acuity & acceptable color vision).