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Sr. Quality Engineer (Operations)

Company: BD Medical
Location: Baltimore
Posted on: December 5, 2019

Job Description:

Locations ========= Baltimore, Maryland Job Description Summary ======================= The Senior Quality Engineer has responsibility for applying/interpreting the applicable Quality Systems, developing/implementing the Standard Operating Procedures and policy s for an organization, such as Quality control, or a manufacturing plant. 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 by assuming the Lead Auditor role 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 CAPAs and may lead the investigation/corrective action process. Knowledgeable in specific automated systems as noted and engaged in new product introductions as a possible Core Team member representing the Quality function. Job Description =============== General: Responsible for all aspects (product and process) related to the quality of the Instrument Plant for the designated product line(s). This includes manufacturability of products at the Instrument Plant, supplier manufacturing, customer requirements and complaints. The Senior Quality Engineer will be responsible for developing and maintaining the Design History File, product and supplier quality. Develops, modifies, applies and maintains quality standards and protocols. General Responsibilities include: 1. Maintain FDA (Food & Drug Administration) and ISO (International Organization for Standardization) regulatory requirements. Key elements of focus are (but not limited to) product design for manufacturability, customer complaints, assembly and test, inspection and validation throughout the development process. 2. Generate process/product quality information in the form of Critical to Quality indices and share with project team/operations recommendations and solutions to emerging issues. 3. Improve key quality metrics (Fist Pass Acceptance, Quality Notifications and Complaint data). 4. Develop department programs / processes on continuous improvement and standardization across the BD Diagnostic Systems. 5. Supports the coordinated integration of new products into Manufacturing / Operations. 6. Ensures BD Diagnostic Systems divisional, departmental policies, procedures, practices and facilities are in compliance with all applicable regulatory policies. 7. Develop Design / Device History Files and maintain in a manner consistent with FDA (Food and Drug Administration) requirements 8. Understanding of Quality Systems and procedures 9. Other emerging responsibilities as identified and assigned. Cost Center Specific: 1. Support new product development teams and being able to represent quality in cross-functional team settings. 2. Perform trend analysis, FMEA (Failure Mode and Effect Analysis) and six sigma tools. Primary Work Location ===================== USA MD - Baltimore Additional Locations ==================== Work Shift ==========

Keywords: BD Medical, Baltimore , Sr. Quality Engineer (Operations), Engineering , Baltimore, Maryland

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