QC Inspector II

Job Description: POSITION SUMMARY RESPONSIBILITIES This position is responsible for, but not limited to, the following: With minimal supervision, performs intermediate visual and dimensional inspection, testing and measurement of components, equipment, and product, in process assembly and/or final inspection. Conducts batch record review and release, including review of NCMR’s, deviations etc., Interprets route tickets, quality inspection documents and deciphers quality expectations for the product. Selects proper AQL samples and reporting inspection and testing data. Approves products by confirming specifications, conducting visual and measurement tests, returning products for re-work and confirming re-work Monitors use of equipment to ensure it is calibrated before use; keeps measurement equipment operating accurately Ensures departmental compliance to all company policies relative to the manufacture of product, lot control requirements, documentation requirements, housekeeping, preventative maintenance, calibration, associate training, and safety (equipment, associate, and material) Performs and documents results of inspections per company procedures. Ensures that all work assignments meet corporate quality and regulatory requirements Recommends activities to promote continuous improvement and best practices Perform other TransMedics tasks and duties as assigned/required. MINIMUM QUALIFICATIONS High School Diploma or equivalent job experience with additional training in the trade; or equivalent combination of education and experience 3 year of Quality Control Experience in Medical Device Manufacturing. Knowledge of clean room operations a plus Understanding of a quality management system (QMS) and cGMP knowledge Must possess intermediate math skills: addition, subtraction, multiplication, division, weights and measures, and efficient use of a calculator Ability to read, interpret, and understand drawings, blueprints, and specifications Detail oriented and follows instructions and specifications meticulously. Must be able to accurately fill out paperwork as required. Intermediate computer knowledge. Flexible and able to work in a fast-paced, dynamic environment PREFERRED QUALIFICATIONS Demonstrated ability to read and write English with ability to follow written instructions or procedures. Strong verbal and written communication skills. Knowledge of inspection tools such as rulers, calipers, or gauges Team oriented with a demonstrated interpersonal skills and positive attitude Ability to independently manage time efficiently Every Organ Wasted is a Life Not Saved. TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients’ lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes. Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health. Maximize your potential at TransMedics, Inc. Employee Benefit: Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA Dental Vision Healthcare Flexible Spending Account Dependent Care Flexible Spending Account Short Term Disability Long Term Disability 401K Plan Pet insurance Employee Stock Purchase Plan TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees. Welcome to TransMedics Careers! Our Vision is to help save more patients' lives by becoming the trusted partner to transplant stakeholders worldwide and delivering the highest quality technology, service and clinical care. TransMedics Group, Inc. (TMDX) is a commercial-stage medical technology company transforming organ transplant therapy for end-stage organ failure patients across multiple disease states. We developed the Organ Care System, or the OCS™, to replace a decades-old standard of care that we believe is significantly limiting access to life-saving transplant therapy for hundreds of thousands of patients worldwide. Our innovative OCS technology replicates many aspects of the organ’s natural living and functioning environment outside of the human body. As such, the OCS represents a paradigm shift that transforms organ preservation for transplantation from a static state to a dynamic environment that enables new capabilities, including organ optimization and assessment. In concert with our OCS technology platform and OCS Connect™ app, which enables TransMedics and transplant clinicians to efficiently track, coordinate & communicate resource logistics for donor organs procured and maintained on OCS™, TMDX launched its National OCS™ Program (NOP) in 2022: 16 regional hubs across the U.S. staffed by a dispersed workforce of experienced, on-staff OCS Perfusion Specialists & Cardiothoracic and Abdominal Donor Procurement Surgeons. These resources are mobilized on-demand via our own dedicated ground & aviation transportation logistics network, to retrieve and deliver allocated donor organs from anywhere in the U.S. – aiding U.S. Transplant Centers in bidding farewell to the time & distance limitations of cold storage & expand the pool of viable donor organs for their transplant recipients.