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Becton, Dickinson and Company
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Senior Quality Scientist Lab Lead at Becton Dickinson & CompanyAsset 1
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Senior Quality Scientist Lab Lead
Job ID R-****** Date posted 04/13/2018
Job Description Summary
s directed by the Quality Manager - Plant, the Senior Quality Scientist Lab Lead is accountable for operation and maintaining lab facilities to support complaint investigations, new product development, manufacturing, and the metrology capability for the Advanced Diabetes Care Platform through the application of Quality engineering skills for medical devices. Metrology is defined as the science of measurement and is critical to BD ADCs success in the design, development, molding and manufacturing of all product lines. The Sr. Quality Engineer will provide technical support for test method development in the areas of Metrology. This associate will handle projects and tasks, from product inception for pilot manufacturing, and product launch. The candidate will play an active role in the processes to ensure products meet quality standards consistent with both Corporate and Unit policies, while meeting all design control and other regulatory requirements.
The Senior Quality Scientist Lab Leadwill work as a member of cross-functional project teams engaged in new product development and manufacturing for electrical, mechanical, and software driven medical devices. The individual will serve as a quality representative on project teams.
Job Description
- gy test methods.
- Administration of test methods, measurement program data files system and software qualification to ensure ongoing compliance and control in line with the internal and regulatory procedures.
- Conduct Gauge Repeatability & Reproducibility and Measurement System Analysis studies and support failure investigations.
- Programming of measurement systems, including Coordinate Measurement Machine (CMM) and visual measurement systems (OGP).
- Perform regular metrology and test system reviews / audits and status reporting to identify potential issues and system status.
- Upkeep of metrology and materials testing equipment to ensure they are adequately maintained, and where required calibrated and validated.
- Documentation and qualification of metrology test methods.
- Perform inspection and test method development and validation. Develop quality plans for receiving, in-process and final inspection.
- Understanding and applying the Six Sigma methodology including Define, Measure, Analyze, Improve and Control and participate on improvement projects.
- Support CAPA, non-conforming material handling, supplier management, complaint handling and procedure development.
- Prepare technical documentation including plans, procedures and reports.
- Support quality / regulatory audits and FDA inspections.
Primary Work Location
USA MA - Andover
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Job Type
Permanent
Job Reference
f837c93361cab75
Job ID
19616156
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Company info
Becton, Dickinson and Company
Website : http://www.bd.com/
Company Profile
BD is a medical technology company that serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public. BD manufactures and sells a broad range of medical supplies, devices, laboratory equipment and diagnostic products. BD is headquartered in the United States and has offices in more than 50 countries worldwide.
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