Quality Engineer II - Liquid Media

Becton Dickinson Medical Devices•Hunt Valley, MD

25d•Onsite

About The Position

The Quality Engineer II supports quality engineering for Media manufacturing operations. The role develops, implements, and maintains Quality System procedures, SOPs, and quality policies; leads validation activities and recurring process and equipment qualifications; and monitors and analyzes quality indicators for purchased materials, manufactured products, and distributed components. The position assesses Critical to Quality parameters and risks, applies statistical analysis and root-cause methods to resolve quality issues, and supports CAPAs and process-control initiatives. The role manages day-to-day Quality Management Engineering activities for assigned products and projects, partners with manufacturing, engineering, and cross-functional teams on launches and process improvements, and promotes consistent Quality System implementation across new and existing product lines. It helps ensure compliance with FDA regulations, ISO standards, and other applicable requirements; supports change controls, product quality notifications, post-market activities, IVDR compliance, and customer complaint investigations; uses enterprise systems and quality tools; and serves as a subject matter expert during audits as needed. The position is based at the USA MD - Hunt Valley work location. BD indicates that most roles require at least four days of in-office presence per week; remote or field-based arrangements are identified separately in postings.

Requirements

Bachelor's degree in Biological Sciences, Chemistry, or another related science field.
At least 2 years of experience in Quality or Engineering.
Moderate knowledge and understanding of FDA 21 CFR 820 and ISO 13485 and 14971.
Ability to manage multiple tasks and drive execution of change management plans.
Ability to lead or manage process control, supplier quality, and continuous improvement projects using statistical techniques and tools, including statistical sampling, SPC, and Six Sigma.
Ability to use systematic analytical tools, including Six Sigma, root cause analysis, failure analysis, and risk assessment, to analyze moderately to highly complex information.

Nice To Haves

Experience in technical writing and executing process or test-method validations.
Experience in a medical device or pharmaceutical manufacturing facility.
Knowledge of automated systems for filling and packaging.

Responsibilities

Develop, implement, and maintain Quality System procedures, Standard Operating Procedures (SOPs), and quality policies.
Lead and execute validation activities, including change validations and recurring process and equipment qualifications for Media plants and IDAST.
Monitor, trend, and analyze quality indicators for purchased materials, manufactured products, and distributed components.
Assess Critical to Quality (CTQ) parameters and perform risk assessments to support product quality, process predictability, and decision-making.
Apply statistical tools and data analysis techniques to identify root causes, resolve quality issues, and implement corrective actions.
Initiate and support Corrective and Preventive Actions (CAPAs), including leading investigations and corrective action activities when required.
Support process control initiatives and promote consistent manufacturing practices across operations.
Identify and recommend continuous improvement opportunities to enhance product quality, operational efficiency, and compliance.
Manage day-to-day Quality Management Engineering activities for assigned products and operational projects.
Partner with manufacturing, engineering, and cross-functional teams to support product launches, process improvements, and quality initiatives.
Ensure consistent implementation and application of Quality Systems for new and existing product lines.
Maintain compliance with FDA regulations, ISO standards, and other applicable quality and regulatory requirements.
Support change controls, product quality notifications, post-market activities, IVDR compliance, and customer complaint investigations.
Use enterprise systems and quality tools to drive compliance, documentation accuracy, and process efficiency.
Serve as a subject matter expert during internal and external audits, as needed.
Foster collaborative and inclusive working relationships across departments supporting Media manufacturing operations.