Job Description

Summary - The Senior Quality Engineer has responsibility for applying/interpreting the applicable Quality Systems, developing/implementing the Standard Operating Procedures and policies 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. Who We Are BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare sector. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health. 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 ofCritical 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). This includes closure of complaint investigations and associated trending for assigned platform(s) 4. Supports the coordinated integration of new products into Manufacturing / Operations and existing products to transferred Manufacturing sites. 5. Ensures BD Diagnostic Systems divisional, departmental policies, procedures, practices and facilities are in compliance with all applicable regulatory policies. 6. Develop and/ maintain Design / Device History Files and maintain in a manner consistent with FDA (Food and Drug Administration) requirements 7. Understanding of Quality Systems and procedures, including maintaining of risk files and environmental files for the products. 8. Manage calibration records in BMRAM. 9. Manage documents in SAP system. 10. Training management for local team. 11. Supplier auditing and monitoring as issues arise (including SCAR management) and drive to resolution. 12. Support the maintenance of the approved supplier list and ensure supplier records are kept up to date and are maintained. 13. Closure of nonconformances in manufacturing 14. Individual contributor to CAPA 15. Individual contributor to MRB 16. Managing deviations and change management/change control 17. Other emerging responsibilities as identified and assigned. 18. Cost Center Specific : Support new product developmentteams and being able to represent quality in cross-functional team settings.Perform trend analysis, as appropriate. Maintain risk files including FMEA (Failure Mode and Effect Analysis) using appropriate tools. Culture and Benefits Here at BD, we embrace a growth mindset, building capabilities for the future and helping you become the best version of yourself.We offer our employees a clear direction and career pathway for development. We pride ourselves on our transparent and rigorous talent processes that are inclusive, deeply embedded in trust, aligned with our culture, and enable us to achieve strategic imperatives of the organization. Our leaders are committed, engaged and accountable to making talent our top priority. How To Apply Submit your application by clicking on the \'apply\' button at the top of the page.Primary Work Location MYS Penang - Bayan LepasAdditional Locations Work Shift

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