The Director of Quality Assurance & Regulatory oversees the compliant functioning of the Xoft Quality Management System (QMS) to industry Standards and Regulatory requirements specific to the domestic and international markets where the Xoft products are commercialized.
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 Xoft QMS to industry Standards and Regulatory requirements in combination with utilizing the best industry practices for assuring the product safety and reliability.
Serves in the capacity of the Site Management Representative for Regulatory and government safety audits, while interfacing with Notified Bodies, State Regulators, and other outside legal entities on matters concerning the Xoft QMS compliancy and facility with government regulations and Local and State laws.
Manages the department functions, personnel and other resources to ensure that the site projects are sufficiently maintained with Quality Assurance & Regulatory 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 Xoft Training Program ensuring that employees are trained to the current SOP’s, work instructions, and safety requirements.
Performs the Regulatory assessments and market strategies for new and existing products.
REQUIREMENTS / EXPERIENCE:
Ten (10) plus years-experience in medical device Quality Assurance in the capacity of a Quality Engineer, Project Leader, Supervisor, or Manager.
Five (5) years-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.
EDUCATION / TRAINING:
BS degree, or equivalent relevant experience
TRAINING and/or CERTIFICATIONS:
ASQ Certified Quality Engineer or Certified Quality Manager is a plus.
Certified RAPS Professional is a plus.
San Jose, CA
iCAD delivers innovative cancer detection and radiation therapy solutions and services that enable clinicians to find and treat cancers earlier and while enhancing patient care. iCAD offers a comprehensive range of upgradeable computer aided detection (CAD) and workflow solutions to support rapid and accurate detection of breast, prostate and colorectal cancers. iCAD’s Xoft® Axxent® Electronic Brachytherapy (eBx®) System® is a painless, non-invasive technology that delivers high dose rate, low energy radiation, which targets cancer while minimizing exposure to surrounding healthy tissue. The Xoft System is FDA cleared and CE marked for use anywhere in the body, including treatment of non-melanoma skin cancer, early-stage breast cancer and gynecological cancers. The comprehensive iCAD technology platforms include advanced hardware and software as well as management services designed to support cancer detection and radiation therapy treatments. For more information, visit www.icadmed.com or www.xoftinc.com.