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Staff Quality Engineer

  • Anywhere

Company :
CareFusion

Location :
Sparks, Maryland

Expiry Date :
Mon, 07 Dec 2020 23:59:59 GMT

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Description :
Job Description SummaryThe Staff Quality Engineer I has responsibility for applying/interpreting the applicable Quality Systems, developing/implementing the Standard Operating Procedures and policys for an organization, such as a manufacturing plant or Validation group. Develops and maintains schedules and timelines. Ensures the documentation process remains compliant. The role provides guidance for the various elements of the Quality System, for example, to ensure process control, consistent supplier qualification practices and identifies/recommends opportunities for continuous improvement (internal/external). Applies the appropriate statistical tools to analyze data, identify root cause and corrective actions for effective problem resolution of moderate to difficult scope and complexity. May support both internal and external audits. Job Description Extensive application of technical principles, theories, concepts and quality sciences, tools and systems with measureable / confirmed results. Job – Track record of root cause determination and effective corrective / preventive action implementation – Provides training for product development teams and continuous improvement teams on best practices – Conducts audits as member of a quality system audit team (e.g. SME, etc) – Writes and leads risk management activities including risk management reports and risk analyses – Guides the successful completion of major programs and may function in a project leadership role – Erroneous decisions or recommendations would typically result in failure to achieve major objectives – Provides management with review opportunities at key points and upon completion – Ensures quality conduct of projects, including design, data summary and interpretation, report and manuscript preparation and review adherence to applicable regulations – Decisions, recommendations and results further the achievement of goals critical to organizational objectives – Implements and communicates the strategic and technical direction for the product/project team – Identifies any issues that may delay product or project and recommends appropriate action to be taken – Additional Job Description – Ability and skill to effectively manage multiple tasks and lead execution of change management plans – Ability and skill to lead or manage the Quality function for design projects, reliability concepts for complex systems, validation planning and execution and continuous improvement projects using statistical sampling, six sigma root cause analysis tools and project management techniques – Ability to effectively write communications that ensures clarity, accuracy and consideration of the audience – Ability to speak with clarity and express points of view in a variety of settings; one-on-one interactions, group meetings, and formal presentations – Ability and skill to analyze using systematic analysis tools that include Six Sigma, root cause, failure analysis and risk assessment to gather critical information and diagnose – Ability to drive for results and effectively work through conflicts in working teams by facilitating conflict resolution – Working knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) EDUCATION: – Bachelors degree with 9 years in experience in the medical device industry where 6 of those years are progressive experience in a specified area – MS with 7 years where 5 of those years are progressive experience in a specified area. – Typical degree in Biological Sciences, Chemistry, Engineering, Regulatory Affairs or other related field. – Demonstrated expertise typically evidenced through certification in at least one of the following ASQ-CQA/CQE, AAMI, AOAC, Six Sigma, or a Company certification such as Green Belt, Black Belt, etc. preferred in a regulated environment Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status. Primary Work LocationUSA MD – Sparks – 7 Loveton Circle Additional Locations Work Shift