<p>Senior Quality Assurance Specialist</p> <p>About This Role:</p> <p>Veranex has an exciting opportunity to join our team as a Sr. Quality Assurance Specialist. You will be part of a team working to improve lives globally through medical technology innovation. The Sr. Quality Assurance Specialist proactively manages the various elements of the quality system to ensure compliance with applicable national and international quality system regulations. This position supports cleanroom monitoring, Preventive Maintenance, quality control, equipment control processes, and maintains QSR/ISO 13485 Quality Systems compliance.</p> <p>What You Will Do:</p> <ul> <li>Responsible for compiling and presenting metrics for NCRs, OOTs, PMs, etc. for monthly operations and management review meetings. </li><li>Perform Risk Assessments for quality observations. </li><li>Support process risk management for novel and existing medical devices (PFMEA) </li><li>Develops, documents, and validates inspection and test methods to support design control, Process Validation, part qualification, in-process inspection, and final inspection activities. </li><li>Provides input and/or oversight for quality system-related activities, including complaint handling, CAPA investigation and supplier evaluations, as needed to assist clients in ensuring product quality and proper implementation of compliant processes. </li><li>Support Quality Control activities such as calibration, preventative maintenance, and inspections. </li><li>Responsible for continuous improvement efforts related to quality processes related to the role. </li></ul> <p>Required skills:</p> <ul> <li>Bachelor's degree in engineering or life sciences, or an equivalent combination of education, training, and experience </li><li>3-6 years of relevant experience </li><li>Strong investigational and communication skills, with a strong skillset to document investigations, perform root cause analysis, and determine corrective action plans </li><li>Strong knowledge of medical device regulations and standards </li><li>Strong knowledge of medical device regulations, guidance documents and standards (i.e., quality system regulations (QSR) International Organization for Standardization (ISO) 13485, ISO 14971, and guidance documents as needed) </li></ul> <p>Preferred:</p> <ul> <li>Experience with different quality management systems </li><li>Provides risk management expertise in the evaluation and design of product </li><li>Experience in design verification and/or validation </li></ul>