Quality Engineer II, Instrument Platforms

Becton, Dickinson and Company; Sparks Corner (MD); On-site; USD 76,000 - 121,000; Full time

Job summary

Becton, Dickinson and Company in Sparks, MD is seeking a Quality Engineer II to ensure compliance with ISO and regulatory requirements across the product lifecycle. You will apply statistical tools and coordinate with cross-functional teams to support new and existing products.

The role emphasizes documenting and improving quality systems, leading CAPAs, and contributing to risk assessments, FMEA, and Six Sigma initiatives.

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.

Responsibilities

• <b>Champion Quality Compliance:</b> Maintain ISO and regulatory requirements across the lifecycle.
• <b>Master Documentation:</b> Develop and maintain Device History Files in full regulatory compliance.
• <b>Drive Quality Intelligence:</b> Generate CTQ indices and provide actionable recommendations.
• <b>Lead Product Integration:</b> Support seamless integration of new products into Manufacturing and Operations.
• <b>Ensure Regulatory Excellence:</b> Ensure policies meet all applicable regulatory requirements.
• <b>Mentor and Coach:</b> Share expertise on Quality Systems and procedures.
• <b>Analyze and Optimize:</b> Perform trend analysis, risk management, and Six Sigma tools.
• <b>Variety:</b> Support instrument platforms on sustaining activities.
• <b>Leadership Opportunities:</b> Lead root cause investigations for moderately complex issues.
• <b>Cross-Functional Collaboration:</b> Work with R&D, Operations and other departments.
• <b>Hands-On Problem Solving:</b> Participate on teams, audits, CAPAs, change controls.
• <b>Strategic Impact:</b> Influence product quality and customer satisfaction across portfolio.

Skills

Quality systems

Six Sigma

Statistical methods

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in Biological Sciences/ Chemistry/ Regulatory Affairs

2 years QA/QC or investigations

Medical device/pharma manufacturing experience

SAP experience

Tools

Excel

PowerPoint

Statistical software

Job description

Becton, Dickinson and Company in Sparks, MD is seeking a Quality Engineer II to ensure compliance with ISO and regulatory requirements across the product lifecycle. You will apply statistical tools and coordinate with cross-functional teams to support new and existing products.

The role emphasizes documenting and improving quality systems, leading CAPAs, and contributing to risk assessments, FMEA, and Six Sigma initiatives.