Quality Technician (2nd Shift)
About Aspen We love what we do! At Aspen Surgical we live our values of Customer Focus, Accountability, Collaboration, Innovative Spirit, and Integrity every day. This caring dedication creates and builds exceptional products that drive the industry standard making a real and lasting impact on people's lives around the world. We strive to be the best, while providing the tools, resources, and support needed to set our team members up for success. Do you want to be appreciated for your hard work? Be a member of a dynamic, fast-growing organization? View your job as a joy rather than a burden? Then we have a position for you! Summary: The purpose of this role is to ensure Aspen manufactured products and materials conform to specified regulatory and customer requirements. Evaluate, investigate, contain, and disposition nonconforming products identified by internal monitoring or customer feedback. In This Position, You Will Have the Opportunity toSupport 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 issues What You Need to Succeed in This PositionHigh 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, EtQ QUALITY 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 regulations PHYSICAL 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 accommodation Please 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.