The Manager of Quality Assurance oversees the compliant functioning of the iCAD Quality Management System (QMS) to industry Standards and FDA requirements specific to the domestic and international markets where the products are commercialized.
RESPONSIBILITIES: The key responsibilities of this position include, but are not limited to, the following: • Applies engineering, leadership, and Quality Assurance skills to effectively manage the QMS to industry Standards and FDA requirements in combination with utilizing the best industry practices for assuring the product safety and reliability. • Manages the department functions, personnel and other resources to ensure that the site projects are sufficiently maintained with Quality Assurance representation, and that the daily activities comprising the QMS (i.e., complaint handling, incoming QA inspection, document control processing, etc.) are adequately resourced to maintain business continuity. • Oversees the Supplier Management Program and serves as the primary liaison for the supplier audits. • Coordinates the performance of the Site Management Reviews and the Post-Market Surveillance Reviews. • Oversees the Quality Training Program ensuring that employees are trained to the current SOP’s, work instructions, and safety requirements. • Performs the Quality assessments and market strategies for new and existing products.
REQUIREMENTS / EXPERIENCE: • Five (5) years of experience working with the FDA QSR’s, EU Medical Device Directive (or MDD), ISO 13485, and Health Canada Regulations. • Five (5) years supervisory experience and 2-years-experience interfacing with Notified Bodies and State Regulators in an audit capacity. • General work knowledge of the EU regulations RoHS, REACH and WEEE. • Four (4) years-experience with Quality Statistics, Risk Management, Design Control, and common industry test methods for sterilization, biocompatibility, shelf-life and transportation testing, and electrical safety testing.
TRAINING and/or CERTIFICATIONS: • ASQ Certified Quality Engineer or Certified Quality Manager is a plus. • Certified RAPS Professional is a plus.
Internal Number: 1238
About iCAD, Inc.
iCAD is a global medical technology leader providing innovative cancer detection and therapy solutions. We work passionately to provide precise, powerful healthcare solutions expertly engineered to optimize operational efficiency, clinician confidence and patient outcomes. iCAD offers a comprehensive range of computer aided detection (CAD) and workflow solutions to support rapid and accurate detection of breast and colorectal cancers. iCAD's Xoft System delivers high dose rate, low energy radiation, utilizing electronic brachytherapy to provide expanded treatment options for a range of cancers. Our proprietary, miniaturized x-ray source is isotope-free and operates at 50 kV. With the Xoft System, highly focused therapeutic radiation of the disease target is possible in a minimally shielded setting, while sparing surrounding healthy tissue. The Xoft System is FDA cleared, CE marked, and licensed in a growing number of countries for the treatment of cancer anywhere in the body, including early-stage breast cancer, non-melanoma skin cancer, and gynecological cancers. The comprehensive iCAD technology platforms include advanced hardware and software designed to support cancer detection and radiation therapy treatments. For more information, visit www.icadmed.com or www.xoftinc.com.