Social network you want to login/join with:Job SummarySr Assoc, Quality Systems is responsible for leading the coordination of Change Control activities and ensuring compliance with internal and external Change control requirements. The role will serve as the subject matter expert and administrator for change control documentation.Essential Duties and ResponsibilitiesOversee overall global Change Control process; leading change control review board activities (documentation, data, customer notifications and approvals, etc.)Collaborate with cross functional teams on West change controls and provide guidance and Quality consultation to change control owners on change levels and associated tasks.Assist change owners to outline action plans, tasks and responsibilities to ensure execution of changes occur in a timely mannerDrive visibility and oversight to changes across network to ensure applicability and consistency.Oversee assessment of change controls and ensure change impact is considered across products, platforms, life cycle phases, supply chain, and processes (i.e., combination products).Ensure change control information is accurately entered into the appropriate tracking databaseProvide mentoring and training to change owners on change control processes and toolsWork with global, cross-functional groups, manufacturing sites, and customers as needed to determine compliance with customer specifications.Monitor and communicate metrics and trend reports to management for the Change Control system as neededCollaborate on cross functional teams in determining specification content.Evaluate change control processes and tools to drive continuous improvement activities.Additional ResponsibilitiesEnsure adherence to corporate Quality System requirementsEducationBachelor's Degree in Science or equivalent experience requiredMaster's Degree in Science or equivalent experience preferredWork ExperienceMinimum 5 years of experience in regulated Quality Assurance / Quality Control requiredExperience with qualifications, Quality Risk Management, quality systems such as ISO 13485, 21 CFR 820, ISO 14971, Medical Device Product Development Life Cycle Activities, Verification / Validation Activities, Risk Management, DHF Activities, MasterControl, SAP, SharePoint, Teamcenter preferredPreferred Knowledge, Skills and AbilitiesAbility to work independently, multi-task and thrive in fast-paced environmentExcellent critical reading and writing skillsEffective problem solving and interpersonal skillsProblem solving including root cause failure analysis methodsPlanning/organizational skillsProficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and PowerPointAble to comply with the company’s safety policy at all timesKnowledge of cGMP, cGDPLicense and CertificationsTravel RequirementsUp to 13 business days per year (5%)Physical RequirementsSedentary work involving sitting most of the time, exerting up to 10 lbs/4 kgs of force occasionally.Additional RequirementsAdaptable to changes, manage competing demands, and deal with unexpected events.Work well with others in various situationsMulti-task, prioritize, and problem solve under time constraintsMake independent and sound judgmentsAnalyze and interpret situations, maintain high attention to detailCommunicate effectively with internal teams and customersFollow SOPs as per company policy and Quality Manual
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