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.