Quality Systems Engineer II - Instrument Plant

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

Job summary

BD in Sparks, MD is seeking a Quality Engineer II to ensure compliance with ISO 9001, ISO 13485 and FDA regulations across design, manufacturing and testing. You will leverage Six Sigma tools, lead root-cause investigations, and support CAPAs while collaborating with R&D and Operations to build quality in from day one.

You’ll analyze data, manage device history files, and contribute to continuous improvement in a fast-paced medical device environment.

Qualifications

• Knowledge of quality systems and regulatory frameworks.
• Experience with Six Sigma and data-driven problem solving.
• Familiarity with medical device regulations (FDA, ISO 13485).
• Experience with audits and CAPA processes.

Responsibilities

• Maintain ISO and regulatory requirements across product lifecycle.
• Develop and maintain Device History Files per regulatory needs.
• Perform trend analysis and risk assessment to drive improvements.
• Lead root-cause investigations for moderately complex issues.
• Collaborate cross-functionally with R&D and Operations.
• Support new product integration with quality built in from day one.

Skills

Quality systems

Six Sigma

Data analysis

Regulatory knowledge

SAP

Audits

Education

Bachelor’s degree in Biological Sciences/Engineering

Tools

SAP

MS Office

Job description

BD in Sparks, MD is seeking a Quality Engineer II to ensure compliance with ISO 9001, ISO 13485 and FDA regulations across design, manufacturing and testing. You will leverage Six Sigma tools, lead root-cause investigations, and support CAPAs while collaborating with R&D and Operations to build quality in from day one.

You’ll analyze data, manage device history files, and contribute to continuous improvement in a fast-paced medical device environment.