Advanced Quality Engineer

Job Description

Summary:

The scope of the position encompasses, but is not limited to development and audit of inspection criteria and methods, technical and statistical investigation on quality problems and complaints, product and process validation, vendor audits.

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

• Reviews inspection criteria, inspection methods and procedures to assure acceptable quality standards at the most economic level

• Performs Quality Engineering activities to support product transfers from pilots and acquisition. Also provides operator training, validation of process lines, development and execution of protocols for validation

• Provides support and assures cGMP's compliance in product and process validations and product and process transfers

• Monitors quality trends and conducts technical and statistical investigations on quality problems, reporting the results and recommendation in a timely manner

• Performs and approves IQ’s, OQ’s and PQ’s of manufacturing, packaging, test and inspection equipments and / or process performance validations

• Conducts audits to assure compliance to BD procedures and specifications, as well as to regulatory requirements

• Plays a key role in ensuring that the Corporation and customer's quality requirements are met on assigned products, programs, areas, and functions. Accordingly, participates in the review of all develop, manufacturing, purchasing and test documentation to ensure that those requirements are fulfilled. This includes review of design drawings, operation documents, process procedures, test procedures, inspection analysis, Vendor Quality Manuals, and customer and military specifications

• Provides technical and quality support to suppliers, the Manufacturing Engineering group and to the Customer Service department on the analysis of product returned from the field

• Reviews quality patterns and plans overall defect reduction programs associated with their assigned products or program. Such trend information is available from formal sources, such as the quality reports and informally through frequent interaction with Supervisors, Inspectors and Production personnel

• Interacts with representatives from a variety of functional groups, including Design Engineering, Manufacturing Engineering, Purchasing, The Financial Department, and all production and inspection personnel in the facility. Also, shall evaluate customer complaints to identify any failure trends. This may require frequent interface with Division Field Assurance Department and suppliers on quality engineering issues

• Reviews all documentation related to product quality such as test procedures, raw material, specifications, operational procedures, etc. and approves as appropriate to ensure product quality

• Improves systems, monitors performance, and identify skills, training and capabilities needed

• Monitors inspection and test results and initiate corrective actions to maintain acceptable levels

• Participates in budget preparation control expenses within the approved plan and participates in Cost Reduction Programs

• Assures is trained before performing any task

• Uses the required clothes, personal and security protective equipment according to the requirements of its operation

• Aligns with the cGMP’s, Quality Standards and established policies and/or procedures

• Performs other duties assigned by the supervisor.

• Must be thoroughly knowledgeable on CGMP's, ISO 9000, OSHA and familiar with other Regulatory Requirements applicable to a…