Quality Control Technician
Le Maitre
Quality Assurance SpecialistThe person in this position will uphold and improve the product quality of medical devices manufactured and meet regulatory requirements for compliance. Apply best practices from within the field of quality to ensure that the materials, components, processes, and manufacturing techniques are used to produce high quality and reliable productsResponsibilitiesResponsible for the proper selection, inspection, and document review of all raw materials, in compliance with approved specificationsInspect items to parameters listed on drawings or quality/material specificationsAdeptly read and/or utilizing pin gauges, rulers, micrometers, calipers, microscopes, and other inspection equipmentInitiate nonconforming material reports or notices for items not meeting applicable specificationsPerform manufacturing audits to ensure that manufacturing procedures are properly followed and that products are tested in accordance with approved test plansMaintain security and integrity of quarantined components and devicesExecute activities associated with inspection methods, calibration, maintenance, and record keepingPerform data collection and limited data analysisCoordinate calibration activities as necessaryCoordinate and conduct rework and inspection and testing of materials and/or finished goods, as needed, to verify that they meet specificationsAssist with administrative functions and supports other department tasks as neededPerform and assist with incoming material receipt and disposition. Notifies Quality and Operations of all nonconformancesIssue batch records and production work ordersReview production documentation for labeling compliance on current productsReview quality and manufacturing records for completion and accuracyParticipate in documentation scanning / archiving processesPerform and assist with facility environmental control data collection and ensures conformity is achievedPerform periodic scheduled and unscheduled walk-through review of the manufacturing process, warehouse storage, and associated production areas to ensure that cGMPs are being followedAdditional duties, as requestedQualificationsHigh School Diploma, or equivalent. Associate's degree, preferredOver 5 years of equivalent experience in a related field, preferably in Medical DeviceExperience in using MS Word, Excel, Power Point and OutlookStrong oral and written communication skillsEEO StatementIn order to provide equal employment and advancement opportunities to all individuals, employment decisions at LeMaitre Vascular will be based on merit, qualifications, and abilities. LeMaitre Vascular does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, breastfeeding or related medical conditions, religious dress, military or veteran status or any other characteristic protected by law.This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination, and access to benefits and training.Applicants with disabilities may contact LeMaitre HR coordinators via telephone, fax, e-mail, and other means to request and arrange for accommodations. If you need assistance to accommodate a disability, you may request an accommodation at any time. Please contact LeMaitre HR at View email address on click.appcast.io.
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