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Job description
Quality Assurance SpecialistIn This Position, You Will Have the Opportunity to:Support validation and risk build activities with manufacturing and engineering groupPerform Customer Complaint Investigations, including customer complaint product dispositions and being the point of contact for quality related customer communicationsPerform root cause analysis, identify solutions and implement effective corrective action for internal nonconformances, customer complaints and CAPA'sInitiate non-conforming dispositionsInitiate CR's and CO'sWrite, train and ensure the proper implementation of Quality Alerts, rework instructions and planned deviations.Maintain, review, and make updates to manufacturing and purchasing Control Plans in IFSMaintain relationships with suppliers and actively drives continuous improvementParticipate with Supply Chain in supplier selection process and purchased materials cost reductionPerform FAI for new product and product changesMaintain supplier quality files and performs audits as necessary per the QMSContinuously identify areas of improvement in the manufacturing processes to ensure compliance or that would enhance product quality and partner with manufacturing to implement the improvementsAnalyze improvement opportunities through MRB monitoringDevelop trainings to build quality awarenessSupport manufacturing and engineering to resolve technical issuesWhat You Need to Succeed in This Position:High School Diploma or equivalent3+ years of experience responsible for Quality improvement projects preferred3+ years of experience in a regulated industry experience that includes FDA and ISO requirements preferredCommunication – displays developed interpersonal skills: leadership, team orientation, ability to communicate at all levelsFlexibility and Adaptability – make effective decisions and maintain effectiveness under changing circumstances and prioritiesTeamwork, communication, positive attitude required to support the manufacturing environmentAbility to read and analyze technical prints and drawingsProblem Solving – able to perform root cause analysis and implement effective corrective actionsProject Management – able to effectively manage and complete multiple projects simultaneously. Computer Skills – Excellent computer skills including but not limited to Microsoft Office Suite, IFS, EtQQUALITY AND REGULATORY REQUIREMENTS:Knowledge of quality system including the quality manual, quality policy and applicable procedures and work instructionsEstablish, implement, and maintain the quality system in accordance with FDA Quality System Regulation, ISO 13485, European Union Medical Device Regulations, and MDSAP participating countries regulationsPHYSICAL REQUIREMENTS:NOTE: The inability to perform any of the following physical requirements does not preclude an applicant from consideration unless, following an individualized analysis, it is determined that the physical requirement is an essential job function and the applicant is unable to perform such function with or without reasonable accommodationPlease refer to Essential Duties and Responsibilities.We're proud to be an equal opportunity employer- and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status. Diversity makes us better.
Worksite address
caledonia, MI, 49316, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.