Quality Engineer II, Liquid Media — QA & Compliance

BD; Cockeysville (MD); On-site; USD 76,000 - 121,000; Full time

Job summary

BD is seeking a Quality Systems Engineer to develop, implement, and maintain procedures ensuring FDA and ISO compliance. You will lead validation activities and monitor quality indicators across media plants, partnering with manufacturing and QA for product launches and improvements.

The role emphasizes on-site collaboration at USA MD - Hunt Valley, with strong data analysis and audit capabilities. BD highlights a culture of excellence and a commitment to patient safety.

Qualifications

• Bachelor's degree in Biological Sciences, Chemistry, or related field.
• 2 years experience in Quality or Engineering.
• Strong written and verbal communication; ability to manage multiple tasks.

Responsibilities

• Develop, implement, and maintain Quality System procedures, SOPs, and quality policies.
• Lead validation activities, including change validations and qualifications for Media plants and IDAST.
• Monitor, trend, and analyze quality indicators for materials, products, and components.
• Assess CTQ parameters and perform risk assessments to support product quality and decision-making.
• Apply statistical tools and data analysis to identify root causes and implement corrective actions.
• Initiate and support CAPAs, including leading investigations and corrective actions.
• Support process control initiatives and promote manufacturing consistency.
• Identify and recommend continuous improvement opportunities to enhance product quality and efficiency.
• Manage QM Engineering activities for assigned products and projects.
• Partner with manufacturing, engineering, and cross-functional teams for launches and improvements.
• Ensure GMP/ISO compliance across new and existing product lines.

Skills

Quality system knowledge

Statistical analysis

CAPA management

Root cause analysis

Regulatory compliance

Documentation

Education

Bachelor's degree in Biological Sciences or Chemistry

Job description

BD is seeking a Quality Systems Engineer to develop, implement, and maintain procedures ensuring FDA and ISO compliance. You will lead validation activities and monitor quality indicators across media plants, partnering with manufacturing and QA for product launches and improvements.

The role emphasizes on-site collaboration at USA MD - Hunt Valley, with strong data analysis and audit capabilities. BD highlights a culture of excellence and a commitment to patient safety.