Calibration Technician / Environmental Monitoring Coordinator / Internal Auditor
CurrentAngioDynamics is a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, surgery, and oncology. This site is an FDA-approved, ISO 13485 facility.– Coordinate and manage calibration program; perform calibrations and lead the department.– Contribute to development of Calibration department’s $70K annual operating budget, and monitor expenses against budget to control and reduce costs. Set and maintain calibration schedules.– Oversee development and implementation of calibration methods and procedures for inspecting, testing, and evaluating precision, accuracy, and reliability of test equipment and processes. Support third-party audits of calibration system. Coordinate internal and external calibration of equipment. Act as a liaison to resolve calibration-related issues with vendors or company’s other facilities.– Track and investigate out-of-tolerance conditions. Assist in determining root causes and impact on product and / or processes. Implement appropriate actions to address failures and minimize potential impact on affected products.– Investigate and write nonconforming reports (NCR), then assist in corrective actions.– In charge of environmental health and safety (EHS) for the site for the past five years.– Perform quarterly clean room (environmentally controlled room, ECR) environmental monitoring of air and surface microbial samples and air particulates. Review results and make procedural updates.– Adhere strictly to AngioDynamics safety policies and procedures. The team at this site has gone over 1400 days (and counting) without an OSHA recordable injury; totaling over 650K man-hours.– Trained employees to serve as alternates in environmental monitoring and calibration activities. Assisted with transition training as facility is closing; went to Glens Falls, NY twice to train.– Performed internal audits, improving process consistency while adhering to FDA and ISO standards.