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Sr Manager of Manufacturing Quality
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Redmond, United States Medline Industries - Transportation & Operations Full timeJob SummaryRead on to fully understand what this job requires in terms of skills and experience If you are a good match, make an application.Job DescriptionJOB SUMMARYResponsible for leading the quality and compliance for applicable products and processes for assigned department(s). Set organizational priorities, oversee resource utilization and develop...
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Sr Manager of Manufacturing Quality
4 weeks ago
Quality And Compliance ManagerResponsible for leading the quality and compliance for applicable products and processes for assigned department(s). Set organizational priorities, oversee resource utilization and develop operational plans and policies.Major responsibilities include:Monitor and maintain compliance with applicable (ex. QSR, GMP, ISO) pertaining to the applicable life cycle and regions of distribution for the product.Act as liaison with the Leadership of Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products, on time delivery, and customer satisfaction.Devise and implement effective communication strategies with Divisions, Suppliers, Manufacturing, and/or Operations Executives and other internal and external Stakeholders.Leads the process and team during investigations and identifying resolutions for issues relating to product or production quality by interfacing with Divisions, Suppliers, Manufacturing, and/or Operations.Devise and implement continuous improvement initiatives, develop and share best practices, and participate in policy setting activities.Oversee the execution to the resolution of all quality issues.Provides leadership support during internal/external regulatory audits.Management responsibilities include:Typically manages through multiple Managers and/or SupervisorsOversee major projects/programs/outcomesBudget responsibilityInterpret and execute policies for departments/projects and developsRecommend and implement new policies or modifications to existing policiesProvide general guidelines and parameters for staff functioningHiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.Minimum job requirements:Typically requires a Bachelor's degree in Engineering, Science, or Technical Field.Work experience:At least 5 years of experience related to the design/operation of medical device or drug combination product platforms, design controls, risk management, including working in compliance with QSR/GMP/ISO requirements or other regulated industries (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR).At least 2 years of management experience. Knowledge / Skills / Abilities Depth of technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR etc.)Proficiency in analyzing and reporting data and performing statistical analysis in order to identify issues, trends, or exceptions to drive improvement of results and find solutions.Demonstrated ability to control and coordinate concurrent projects, competing priorities and critical deadlines.Advanced skill level in Microsoft Excel (for example: pivot tables and reporting, conditional formatting, tables, formulas, charting, etc.).Position requires travel up to 30% of the time for business purposes (within state, out of state and/or internationally).Preferred job requirements:Work experienceAt least 4 years of managerial experience preferred.At least 6 years of related experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products industries preferred.
