Home Job Postings Quality Assurance This topic has replies, 0 voices, and was last updated 6 years ago by Sigmagraft, Inc. Now Editing “Quality Assurance” Name * Password * Email Topic Title (Maximum Length 80) Company * Location Expires at ESSENTIAL JOB DUTIES • Perform raw material incoming inspections including and packaging material checks to ensure requirements are met— document and communicate results. • Perform Daily Operating Inspections as needed to assure compliance with GMPs requirements. • This position is responsible for day-to-day QA sampling collections that includes (but is not limited to) all sampling required for company bioburden control programs. • This position will maintain accurate collection and record keeping of all sampling information, audit results and other project information. • This position also performs scheduled facility audits and all documentation pertaining to those audits. • Report and follow-up on quality concerns. • Assists in customer concern investigations, including evaluation of retains, returned product, and raw materials to help determine concern validity and investigate root cause. • Document establishment, review and approval Required Qualifications • Bachelor’s degree • Relevant work experience in a medical device, pharmaceutical, or food processing industry field. • Experience with FDA requirements, knowledge of regulations such as GMP, ISO 13485 and other international regulatory requirements preferred, but not required. • Previous experience with Quality Management System development, implementation, and monitoring. • Knowledge of quality systems, technical writing and training skills is preferred. • A strong working knowledge of Microsoft Excel, Microsoft Word, Microsoft PowerPoint and Microsoft Outlook. • Excellent communication, organizational, analytical and interpersonal skills. • Must be a person of passion and integrity who has the drive to excel and deliver exceptional results. Highly qualified candidates will also possess: • Previous experience working with the ISO 13485 quality management system • Previous experience with FDA cGMP • Experience with ISO and/or FDA audits • The ability to solve practical problems or issues • The ability to communicate and interact with coworkers in a positive manor • The ability to work swiftly and accurately • The ability to recognize and solve practical problems or issues I agree to the terms of service Update List
