Job Description Summary

The Staff Quality Engineer is a key member of the Dispensing Service Quality Team and is responsible for developing and maintaining data streams that are used to measure post market quality signals. This position ensures that quality engineering principles are applied to data analysis and sustaining engineering projects.

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. 

Quality Engineering is responsible for product and service quality evaluation and control. Works cross-functionally in the development and/or maintenance of products or services. The Engineer is involved in resolving the equipment and process-related production issues, activities including equipment, process, materials and method validation as well as statistical analysis and metrics to analyze those systems and processes being measured.

 

What is expected of you for success in your role:

• Demonstrates strong knowledge of quality engineering policies, principles and best practices

• Understanding of regulatory and international standards requirements including 21 CFR 210, 211, ISO 13485, ISO 14971 to support work with little or no supervision

• Applies comprehensive knowledge of software quality concepts within the software development lifecycle

• Knowledge of programming languages used to analyze post market signa (Python, SQL)

• Represents Quality organization on cross-functional product development Core Team(s)

• Identify risks and proactively work with the program team to document risks and help to develop and ensure mitigation plans are in place

• Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc…)

• Applies knowledge and skills to a wide range of standard and non-standard situations

• Works independently with minimal guidance

• Usually determines own work priorities

• Acts as a resource for colleagues with less experience

Duties include:

Developing and maintaining tools in the various systems that the business uses to measure post market quality. These systems include:

• Microsoft SQL Server, SSIS, Azure: Data Factory, Synapse Analytics Power BI, AWS: Quicksight, Athena, and machine learning algorithms.

• Languages: SQL and Python

• Provide guidance to the business regarding potential projects to improve the Quality of Dispensing products. These projects include:

• Predictive failure analysis

• Infant mortality rate reduction

• Improving compliance through complaint and service signal analysis

• Create analytical engineered models from various input sources.

• Engage in cloud infrastructure decisions to ensure the needs of the business are met.

• Work closely with internal teams to ensure project timelines are met.

• Works together with Quality Engineers to improve signal integrity of post market quality systems.

• Monitors and ensures compliance with company policies and procedures (e.g. compliance with FDA, BSI, CSA, etc.).

• Identifies areas requiring quality improvement and follows through plans of action necessary for implementation.

• Active participant in the development of product requirements, product system hazard analysis and design reviews.

• Proactively engage partners to drive consensus and resolve issues in a timely fashion.

• Provide statistical support and expertise and analytical problem solving for product development and manufacturing

• Drive continuous improvement effor