Quality & Validation Engineer II

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

Job summary

BD is seeking a Quality Engineer II, Validation to support and maintain Quality Systems across Media manufacturing, focusing on validation writing and execution. You will drive continuous improvement, partner with cross-functional teams, and ensure regulatory compliance within a fast-paced MedTech environment.

Responsibilities include leading validation activities, monitoring quality indicators, and supporting CAPAs and audits.

Qualifications

• Bachelor's degree in a science field required.
• 2 years of quality/scientific operations/engineering experience preferred.
• Experience with validation writing/execution is desirable.

Responsibilities

• Develop, implement, and maintain Quality System procedures and SOPs.
• Lead and execute validation activities for media plants and IDAST.
• Monitor quality indicators for materials and products; perform risk assessments.
• Apply statistical tools to identify root causes and implement corrective actions.
• Support CAPA investigations and ensure regulatory compliance.
• Collaborate with manufacturing, engineering, and cross-functional teams on quality initiatives.
• Ensure compliance with FDA and ISO standards; participate in audits.

Skills

Quality Systems

Validation writing

CAPA investigations

Statistical tools

Technical writing

Audits

Data analysis

Process control

Education

Bachelor's degree in Biological Sciences, Chemistry, or related science field

Tools

FDA 21 CFR 820 knowledge

ISO 13485 / 14971 knowledge

Job description

BD is seeking a Quality Engineer II, Validation to support and maintain Quality Systems across Media manufacturing, focusing on validation writing and execution. You will drive continuous improvement, partner with cross-functional teams, and ensure regulatory compliance within a fast-paced MedTech environment.

Responsibilities include leading validation activities, monitoring quality indicators, and supporting CAPAs and audits.