Quality Engineer II

Job Description

This role provides guidance for the various elements of the Quality System, ensuring process control and consistent manufacturing practices. It identifies opportunities for continuous improvement, applies appropriate statistical tools to analyze data, and supports both internal and external audits as a subject matter expert.

• Monitor and trend quality indicators for purchased materials as well as manufactured and distributed components/products.
• Assess Critical To Quality (CTQ) parameters and risk assessment variables to support product design and flow.
• Initiate and support CAPAs, leading the investigation and corrective action process.
• Handle Media QM Engineering duties and day‑to‑day QM Engineering responsibilities for assigned products and projects.
• Report directly to the Plant Quality Manager on implementation of Quality Systems for new and current product lines and enterprise business systems.
• Ensure departmental compliance with ISO and FDA requirements; participate on teams, support product launches, process improvements, and manage change notifications, post‑market, IVDR, and customer complaints.
• Use Enterprise tools to ensure compliance and streamline processes.
• Support multiple sites on the Baltimore campus if required.
• Work the 1st shift, Monday through Friday.

• Bachelor's degree in Biological Sciences, Chemistry, or related science field.
• Minimum 2 years of experience in Quality or Engineering.

• Experience in technical writing and executing process/test method validations.
• Experience in a medical device or pharmaceutical manufacturing facility.
• Moderate knowledge of FDA 21 CFR 820 and ISO 13485/14971.
• Ability to manage multiple tasks and drive execution of change management plans.
• Skill to lead process control, supplier quality, and continuous improvement projects using statistical techniques (statistical sampling, SPC, Six Sigma), root cause analysis, failure analysis and risk assessment.
• Excellent written communication ensuring clarity and accuracy.
• Strong verbal communication for one‑on‑one interactions, group meetings, and formal presentations.
• Strong listening skills to gather information from associates, managers, peers, and customers.
• Analytical skills to use systematic tools such as Six Sigma, root cause analysis, failure analysis, and risk assessment for moderately complex problems.
• Knowledge of automated filling and packaging systems is a plus.

USA MD - Hunt Valley

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.