Quality Engineer II - Instrumentation & Compliance

Becton, Dickinson and Company

Maryland

On-site

USD 76,000 - 121,000

Full time

4 days ago

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Job summary

Quality Engineer II at Becton, Dickinson, and Company in Sparks, MD will apply and interpret plant procedures to ensure compliance with quality systems across design, manufacturing, and release. You will leverage statistics, analyze data, and support new and existing product lines.

You will lead quality initiatives, perform risk assessments and Six Sigma projects, mentor teammates, and collaborate with R&D and operations to build quality in from day one, while staying compliant with FDA and ISO

Qualifications

Bachelor's degree in Biological Sciences, Chemistry, or Regulatory Affairs.
2 years’ experience in Quality Assurance, Quality Control, or Product/Process non-conformance investigations.
Experience in a medical device or pharmaceutical manufacturing facility.
SAP transaction experience.
Knowledge of FDA 21 CFR 820, ISO 9000/ ISO 13485 standards.

Responsibilities

Maintain ISO and regulatory requirements across product lifecycle from design to customer resolution.
Develop and maintain Device History Files in full regulatory compliance.
Generate CTQ indices and provide actionable recommendations.
Support integration of new products into Manufacturing and Operations.
Ensure regulatory excellence for divisional policies and facilities.
Mentor teammates in Quality Systems and procedures.
Perform trend analysis, risk management, and Six Sigma applications.
Support audits, CAPAs, change controls and deviations.