Quality Engineer II

Job Overview

Provide guidance for the Quality System elements to ensure process control, consistent manufacturing practices, and continuous improvement. Apply statistical tools for data analysis, identify root causes, and develop corrective actions for moderate‑scope issues. Serve as a subject matter expert for internal and external audits.

• 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 as part of decision‑making processes to support predictable product design and flow.
• Initiate and/or support CAPAs and may lead the investigation and corrective action process.
• Manage Media QM Engineering and day‑to‑day QM Engineering responsibilities for assigned products and operational area projects.
• Report directly to the Plant Quality Manager to ensure consistent implementation of Quality Systems for new and existing product lines and enterprise business systems.
• Ensure departmental compliance with ISO and FDA requirements, support product launches, process improvements, product quality notifications, change notifications, post‑market surveillance, IVDR, and customer complaints.
• Utilize Enterprise tools to maintain compliance and streamline processes.
• Support multiple sites on the Baltimore campus as needed.
• Shift: 1st / Monday – Friday.

• Bachelor’s degree in Biological Sciences, Chemistry, or a related science field.
• Minimum of 2 years of experience in Quality or Engineering.
• On‑site support for the role.

• Experience in technical writing and execution of process/test method validations.
• Experience in a medical device or pharmaceutical manufacturing facility.
• Moderate knowledge of FDA 21 CFR 820, ISO 13485, and ISO 14971.
• Strong project management skills with change management and statistical techniques (SPC, Six Sigma, root‑cause analysis).
• Excellent written and verbal communication skills.
• Ability to handle multiple tasks and set priorities effectively.
• Systematic data analysis skills using Six Sigma, root‑cause analysis, failure analysis, and risk assessment.
• Familiarity with automated filling and packaging systems is a plus.

The role is on‑site in Hunt Valley, MD, with a requirement for a minimum of four days per week in the office. Remote or field‑based arrangements may be specified for other positions but not for this role.

Employment may require proof of COVID‑19 vaccination. The company’s Workplace Accommodations Policy will be considered in accordance with applicable law.

USA, MD – Hunt Valley

$73,300.00 – $ USD Annual

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, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.