Job Title

JOB TITLE: QC Coordinator A POSITION OBJECTIVE: The Quality Control Coordinator will support the Quality Control Manager II; Quality Assurance Engineer and the Quality Department by performing quality functions such as : Device Master Record and Device History Record compilation; creating COC/COA/COQ and sterilization certifications; conducting receiving and shipping inspection; assisting with the maintenance of the document control system and customer complaints; assisting in the root cause analysis investigation with corrective action/preventive action that create solutions to internal and external customer issues, data entry of quality management system data into various company software. Assist all members of the Quality Department with duties as assigned to maintain Quality Management System compliance. QUALIFICATIONS Associate's degree or equivalent from an accredited two-year college/technical school, or higher, is preferred plus 2-4 years of quality experience in a medical device manufacturing environment; or equivalent combination of education and experience. Must have working knowledge of the FDA 21 CFR Part 820 Quality System Regulation. Working knowledge of ISO 13485:2016 Standard is preferred. Current certified ISO 13485:2016 Internal Auditor certificate or internal auditing experience in a manufacturing environment is a plus. Working knowledge of MS Office suite and SAP is a plus. Ensure consistent, dependable attendance and demonstrate a willingness to accommodate non-standard work hours as necessary. Capable of effectively managing job-related stress and fostering productive workplace interactions. JOB RESPONSIBILITIES: Device Master Records (DMR) and Device History Records (DHR) support for production. Assist Quality Technicians with customer complaint system with clerical support, containment, product checks and coordination of quality alerts. Assist Quality Engineer in the writing and change control process of Document Control Library documents. Lead Calibration program and maintain all records control for compliance Maintain all records control as necessary for regulator compliance. Participate in Total Productive Maintenance (TPM) activities in a cross functional departmental team environment. Other duties as assigned by Quality Control Manager II. WORK ENVIRONMENT CONDITIONS SUBJECTED TO IN THIS POSITION: Must be able to work in smoke-free settings, 50% in the office environment utilizing computer, telephone, copier; 50% performing other duties in the facility and interacting with department employees and internal and external customers. Required to frequently talk, listen, stand, walk, sit, bend, stoop, reach with hands and arms, and use hands to finger, handle or feel. Occasionally required to lift up to 50 pounds including production goods, and normal office equipment and supplies Specific vision abilities required by the is job include color, close and ability to adjust focus.