Quality Engineer II

Becton Dickinson Medical Devices•Hunt Valley, MD

15h•$73,300 - $121,000•Onsite

About The Position

This role is with Waters Corporation, a global leader in life sciences formed from the combination of BD Biosciences and Diagnostic Solutions. Waters is dedicated to accelerating pioneering science through analytical technologies, informatics, and service, focusing on regulated, high-volume testing environments. The company's innovative portfolio leverages deep scientific expertise to advance high-quality medicines, ensure food and water safety, and improve patient outcomes by detecting diseases, managing infections, and combating antibiotic resistance. BD, one of the largest global medical technology companies, aims to advance the world of health by finding transformative solutions. This Quality Engineer II role provides guidance for various elements of the Quality System, ensuring process control, consistent manufacturing practices, and identifying opportunities for continuous improvement. The position involves applying appropriate statistical tools for data analysis, root cause identification, and corrective actions for problems of moderate scope and complexity. The incumbent may also support internal and external audits as a Subject Matter Expert (SME).

Requirements

Bachelor's degree in Biological Sciences, Chemistry, or other related science field.
2+ years experience in Quality or Engineering.
On site support

Nice To Haves

Experience in technical writing and executing process/test method validations.
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 13485 and 14971.
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, Six sigma, additionally root cause analysis and project management techniques are routinely employed.
Ability to effectively write communications that ensures clarity, accuracy, and consideration of the audience.
Ability to speak with clarity and express points of view in a variety of settings; one-on one interactions, group meetings, and formal presentations.
Ability to listen to others; including associates, managers, peers and customers when making decisions and solving problems.
Ability and skill to analyze data using systematic analytical tools such as Six Sigma, root cause analysis, failure analysis and risk assessment to gather critical information that has moderate to difficult complexity.
Knowledge of automated systems for filling and packaging are a plus.

Responsibilities

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.
Initiates and/or supports CAPAs and may lead the investigation/corrective action process.
Responsible for the various aspects of Media QM Engineering as well as day to day QM Engineering responsibilities for assigned products and related operational area projects.
Directly responsible to the Plant Quality Manager for the continued consistent implementation/application of Quality Systems as it relates to new and current product lines and Enterprise business systems.
Assuring departmental compliance with ISO and FDA requirements participation on teams, assigned project support, product launches and process improvements, product quality notifications, change notifications, post market, IVDR, and customer complaints.
Using Enterprise tools to ensure compliance and streamline processes.
Position may need to support multiple sites on the Baltimore campus.

Benefits

Comprehensive Total Rewards program.
Reward and recognition opportunities that promote a performance-based culture.
Competitive package of compensation and benefits programs.
Culture that values your opinions and contributions and that encourages you to bring your authentic self to work.
Help each other be great, do what's right, hold each other accountable, and learn and improve every day.
Supported to learn, grow and become your best self.
Culture in which you can learn, grow, and thrive.
Satisfaction in doing your part to make the world a better place.

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