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Cardinal Health

Design Quality Engineer

Cardinal Health - Mansfield, MA

This position is expected to lead and support key post market quality efforts within the DVT NI and Patient Care Businesses.  They will coordinate the investigation of post market assessments, ensure alignment with functional groups, carry out product notifications related to field actions, and deployment of corrective and preventive actions.This role is focused on maintaining and improving process and product performance and monitoring. As such, this position is expected to:Collaborate with all pre and post-production functions (R&D, manufacturing, post market vigilance, CAPA, change development, Supplier Quality, etc.) to ensure the proper application, use and updates of risk management files following product launch.Review and analyze customer complaint trends or significant event to assure appropriate action is taken to address the issue.  Action can include initiate of CAPA or escalation of event to a Health Hazard EvaluationProvide assessment of post-market risk related to field issues and provide response to regulatory body inquiries as necessary.Drive continuous improvement through CAPA by leading, and collaborating with cross functional teams including Quality, R&D, Marketing, and Medical/Clinical Affairs.Create internal communications to support procedural and process requirements and reports for health agencies as required.Support Field action decision and work with different functions and global partners to manage and track field actionsHave excellent communication and documentation skills and practices;Understand therapy and clinical performance, products, and product use environments to appropriately and strategically apply technical knowledge, tools and methodologies to drive product qualityAccountabilitiesThis role supports a wide range of cross-functional teams including Sustaining Engineering and Manufacturing.  As such, this position is focused on maintaining the product integrity through performance monitoring and reporting, post market changes, and supporting/resolving quality issues that arise during post-production and use. Responsibilities include:Follow and maintain quality system policies and procedures to ensure that products and processes meet applicable standards and specificationsCoordinate business meetings to communicate and align on product issues and ensure appropriate decision making is made to initiate actions or support documentation for no action required.Drive global updates to field actions so timely completion is achieved with regional groups. Create and maintain documentation related to internal health risk assessments, field actions, and agency reporting and internal communications.Provide updates for internal reporting and project tracking needs for business management and external requests on defined timeframes and for special requests. Lead and participate in meetings related to product performance, complaint trend reviews, and for CAPA management.Communicate with regulatory agencies on administrative and routine matters in field action activities as defined in procedures and under the direction of management.Evaluate field performance, analyze field performance trends, and recommend corrective action when necessary.Analysis and evaluation of product field returns.Investigate and evaluate field issues with respect to potential health risks (perform and/or lead Corrective Action and Preventive Action activities and prepare Health Hazard Analyses) and work with teams to resolveCollaborate/interface with Clinical, Quality, Marketing, and Product Development on field corrective action plans. Interface directly with customers on issues, as needed.QualificationsB.S. in Engineering or associated scientific discipline.Minimum 4 years medical devices experience in Quality or R&D Engineering position.DFSS or DMAIC Black Belt Certified or Certified Quality Engineer (CQE) or Certified Reliability Engineer (CRE) preferred.Proficient with Minitab.Experience and success managing projects and working with multi-disciplinary teamsExposure to or experience working in or with Design, Quality, Development Engineering, Clinical Affairs, and ManufacturingKnowledge of Design for Reliability (DfR), Design for Reliability and Manufacturability (DRM), and robust design practicesWorking knowledge of product risk management standards and tools (ISO14971, IEC 60601, pFMEA, dFMEA, etc.).Working knowledge of Quality Engineering and medical device regulations (FDA 21CFR 820, 806, 803, 804, ISO13485, and MDD)Working knowledge of electro-mechanical devices, software hazards analysis, and/or plastics related manufacturing processes (i.e. extrusion, injection molding, RF welding, etc.) is preferred.Reliability engineering experience, including product performance modeling and trendingWhat is expected at this levelProven ability to operate in a matrix organization and navigate complex business systems, regulations, standards, and performance requirementsExcellent PROBLEM SOLVING skills, including demonstrated application of structured problem solving methods and toolsDemonstrated CRITICAL THINKING skills with focus on improved system performance outcomes and positive business impactStrong written and oral COMMUNICATION skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience)Strong COLLABORATION and INFLUENCE skills (build relationships, leverage others, align and work towards shared outcome-based goals, understand others’ needs, negotiate for win-win, own the whole)ORGANIZATIONAL RELATIONSHIPS/SCOPE:This position reports to the Sr. Director, Patient Care and DVT/NI Quality, and will routinely interface/collaborate with cross-functional project team members, mangers, plant personnel, and suppliers.Posted 7 Days AgoFull time20033139

18 days 8 hours ago

Cardinal Health

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Design Quality Engineer Cardinal Health - Mansfield, MA, United States

   

Location: Mansfield, MA

Company Profile:
Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a $103 billion health care services company that improves the cost-effectiveness of health care. As the business behind health care, Cardinal Health helps pharmacies, hospitals, ambulatory surgery centers, clinical laboratories and physician offices focus on patient care while reducing costs, enhancing efficiency and improving quality.