Job Description Summary

The Quality Engineer II/Sr title will be determined based on prior experience. The general requirements will be the same. The degree of independence and oversight will vary based on the associate being determined to be a QEII or Sr QE.
This position is responsible 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). Responsibility for process validation across all media plants. Moderate level of application of the appropriate statistical tools to analyze data, identify root cause and corrective actions for effective problem resolution of moderate scope and complexity. Will support both internal and external audits.

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. Responsibility for CAPAs and may lead the investigation/corrective action process.

Responsible for day to day QM Engineering responsibilities for product and related operational areas. Is also responsible for assuring departmental compliance with ISO and FDA requirements through supporting plant trainings and initiatives.

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 MedTech 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. 

Responsibilities:

• Required experience in independently writing and executing process validation protocols.
• Experience in a medical device or pharmaceutical manufacturing facility.
• Moderate knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 13485
• Clinical Diagnostic experience a plus
• Ability and skill to effectively manage multiple tasks and drive execution of change management plans
• Ability and skill to lead or manage process control, supplier quality and continuous improvement projects using statistical technique/tools such as: Statistical sampling, SPC
• Provide on site validations of equipment, software and materials, for the Baltimore/Sparks reagent plants.
• Develops, documents, administers and maintains Quality Systems for conformance, regulatory requirements and company policies.
• Provides advice, updates, and troubleshooting to quality product and processes using technical and enterprise knowledge independently and in team environments.
• Uses tools including FMEA, risk analysis, validation, and project management, sampling plans, Six Sigma, control plans, trending and design control.
• Initiates and/or supports CAPAs and may lead the investigation/corrective action process
• Supports implementation of corrective actions and improvements by initiating and coordinating SAP data/documentation in current products.
• Responsible for initiating and coordinating SAP master data and documentation for product changes and new products.
• Drives for continuous improvement in all areas and participates on Continuous Improvement teams and recommends improvements, implements changes and verifies effectiveness of changes.
• Performs all duties in accordance with all applicable BDDS Quality, Safety and Operating Procedures to support operations day to day.
• Supports internal and external audits and assists in administering the audit program.
• Develops and maintains efficient methods for regularly reporting to management the current status of product quality with respect to Quality objectives and goals and provides plant quali