Quality EngineerResponsible for all areas of Quality Engineering on customer programs. Responsible for working directly with the program management, tooling and manufacturing functions to ensure adequate systems, documentation, inspection methods and tools are used throughout the organization for molding and assembling healthcare products. Understanding customer requirements and implementing appropriate controls, documentation, action plans, and tools necessary to perform quality related tasks at all phases within the process.Essential Job Duties and Responsibilities:Create and maintain pFMEA's, Control Plans, PPAPs, Master Validation Plans, IQ/OQ/PQ protocols and reports.Analyze FAIRs, process and test method validation data before sending to the customer.Lead customer complaints and CAPA investigations as required.Manage ECOs, deviations, and documentation updates as required.Generate and maintain applicable quality system documentation as needed.Manages activities for handling healthcare products from receiving to shipping.Assessing and ensuring compliance through training, auditing, and corrective and preventive actions.Participate in customer audits and provide input to any observations.Train personnel as requiredReview and discuss daily rejects and implement action plansMake appropriate changes to prevent recurrence of quality related issues.Make appropriate changes to fixtures or inspection methods and tools as required.Regular attendance and professionalism.Other Position Duties:Make decisions regarding quality related questions as appropriateContact customers via verbal/written communication as appropriateParticipate in design reviews as requiredVisit customers and suppliers as requiredParticipate in plant/department meetings and tours as requiredWork with Engineering, Manufacturing and Tooling on continuous improvement activitiesMaintain cleanliness of work areas and quality measuring equipmentObserve all health and safety requirements and report any unsafe conditionsOther duties as assignedEssential Qualifications:Bachelor of Science Degree5-10 years of experience as a Quality Engineer in the healthcare industry, with New Product Development or New Product Introduction experience required.Must have experience with ISO 13485 and 21 CFR Part 820 Quality System RegulationMust be able to read and understand 2D detailed part/article drawingsMust understand the use all quality related inspection equipmentMust have excellent problem solving and mistake proofing skillsMust have computer skills and familiarity with Word and Excel programsMust have knowledge of SPCEffective interpersonal and problem-solving skillsNew product development experience- minimum of 2 years' experienceEstablished track record in demonstrating strong leadership and managerial skills within a team-based, collaborative matrixed organizationNice to Have:Experience with validating large-scale automationExperience with 21 CFR Part 4 Combination ProductsADA Requirements:Bend, squat, climb, grasp, reach, lift or otherwise move frequently for extended periodsLift, move or otherwise transfer up to 50 lbs.
frequently, or more occasionallyWalk, stand or otherwise move about continuouslyExposure to machine shop physical hazards including chemicals which may require respiratory protectionTypically sits, grasps items and performs keyboarding for occasional operation of a computerWhat SMC has to offer:Clean, Climate-Controlled EnvironmentStable schedulePaid holiday and PTOHealth, dental, and vision insurance401(k) retirement savingsLife and disability insurancePromotional opportunitiesTraining and career growth programsAmazing co-workersTuition reimbursementEmployee Assistance Program