Responsible for performing incoming inspection, in-process audits and inspection, and final product inspection in conformance with drawings, Engineering Revision Orders, Engineering Changed Notices, workmanship standards, Becton Dickinson policies and procedures, GMP's, CFR 820 and ISO9000 standards. Completes assignments that are moderately complex in nature where good decision making skills are required in resolving problems and making proactive recommendations to continually improve the quality of the product. Must have the ability to effectively interact with all levels of associates, and all functional departments in the organization. Must be capable of independently prioritizing multiple tasks, maintaining inspection data, and analyzing inspection data. Effectively works in a team setting, supporting team goals and objectives.
Duties and Responsibilities
Use decision-making skills and judgment to verify that quality standards are maintained. This includes participating in the implementation of Corrective Action. Independently plan and perform daily work duties, inspections, and tests. Work with minimal supervision to follow BD policies and procedures, and prioritizes multiple tasks.
Cost Center Specific
1. Perform in-process audits, inspections and final release for instruments, spares and repair areas in the instrument plant
2. Perform data analysis and run reports for inspection related activities
3. As required, coordinate and process quality notifications for the instrument floor and incoming functions.
4. Maintain and file Device History Files per regulatory requirements
5. Basic Incoming Inspection of electro mechanical components
1. Ability to read and comprehend complex assembly drawings, test procedures, and component drawings.
2. Reading, writing and basic statistics.
3. Neat, accurate, and complete record keeping.
4. Good administrative and organizational skills and working knowledge of ISO 13485, CFR 820 and cGMP requirements.
5. Attention to detail and process oriented
6. Basic computer skills: Word, Excel, SAP knowledge preferred.
1. High school graduate or equivalent.
2. ASQC CMI or equivalent college education preferred.
1. Three + years experience in quality or a combination of relevant work experience and training. Manufacturing environment background preferred.
Becton Dickinson - 20 months ago