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BD (Becton, Dickinson and Company) Quality Engineer II in Baltimore, Maryland

Job Description SummaryThe Quality Engineer II has responsibility for applying/interpreting the applicable Quality Systems, developing/implementing Standard Operating Procedures and Quality policies. Develops and fosters an inclusive working relationship across all job functions that support the Media plants.

Job Description

Job Description

The role will have primary focus on larger Engineering projects for the Media plants as well as supporting the other Media plant Quality Engineers. This role provides guidance for the various elements of the Quality System, for example, to ensure process control, consistent manufacturing practices andidentifies/recommendsopportunities for continuous improvement (internal/external). Moderate level of application of the appropriate statistical tools to analyze data, identify root cause and corrective actions for effective problem resolution of moderate scope and complexity. May support both internal and external audits as an SME.

Responsibilities include monitoring and trending quality indicators for purchased materials as well as manufactured and distributed components/products. Assesses Critical To Quality (CTQ) parameters and risk assessment variables as part of the decision making processes to support predictable product design and flow. Initiates and/or supports CAPAs and may lead theinvestigation/correctiveaction process. Responsible for the various aspects of Media QM Engineering as well as the day to day QM Engineering responsibilities for assigned product and related operational areas. Directly responsible to the Plant Quality Manager for the continued consistentimplementation/applicationof Quality Systems as it relates to new and current product lines and Enterprise business systems. Is also responsible for assuring departmental compliance with ISO and FDA requirements participation on teams, assigned project support, product launches and process improvements, product quality notifications, change notifications and customer complaints. This includes using Enterprise tools to ensure compliance and streamline processes.

REQUIREMENTS

  • Bachelor's degree in Biological Sciences, Chemistry or other related science field.

  • 2+ years experience in Quality or Engineering.

PREFERRED AND ADDITIONAL SKILLS AND QUALIFICATIONS

  • Experience in a medical device or pharmaceutical manufacturing facility.

  • Moderate knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization ISO 13485

  • Ability and skill to effectively manage multiple tasks and drive execution of change management plans

  • Ability and skill to lead or manage process control, supplier quality and continuous improvement projects using statistical technique/tools such as: Statistical sampling, SPCSix sigma, additionally root cause analysis and project management techniques are routinely employed

  • 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 to listen to others; including associates, managers, peers and customers when making decisions and solving problems

  • Ability and skill to analyze data using systematic analytical tools such as Six Sigma, root cause analysis, failure analysis and risk assessment to gather critical information that has moderate to difficult complexity

  • Knowledge of automated systems for filling and packaging are a plus.

EEO Statement

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, or any other protected status.

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Primary Work LocationUSA MD - Baltimore

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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, or any other protected status.

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