Quality Systems Engineer II

Regulatory Jobs; Maryland; On-site; USD 76,000 - 121,000; Full time

Job summary

BD is seeking a Quality/Engineering professional to lead and maintain QA systems in a regulated, high‑volume manufacturing setting in Hunt Valley, MD. You will drive process validations, CAPAs, and continuous improvement efforts while ensuring FDA 21 CFR 820 and ISO 13485 compliance.

You'll collaborate across manufacturing and engineering teams to support product launches, change controls, and post‑market activities, using statistical tools to reduce risk and improve product quality.

Qualifications

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

Responsibilities

• Develop and maintain Quality System procedures and SOPs.
• Lead validation activities for Media plants and IDAST.
• Monitor quality indicators across materials and products.
• Support CAPAs and corrective actions.

Skills

Process control

Supplier quality

Continuous improvement

Six Sigma

Root cause analysis

Education

Bachelor's degree in Biological Sciences (or related)

Tools

Statistical software

Job description

BD is seeking a Quality/Engineering professional to lead and maintain QA systems in a regulated, high‑volume manufacturing setting in Hunt Valley, MD. You will drive process validations, CAPAs, and continuous improvement efforts while ensuring FDA 21 CFR 820 and ISO 13485 compliance.

You'll collaborate across manufacturing and engineering teams to support product launches, change controls, and post‑market activities, using statistical tools to reduce risk and improve product quality.