Quality Engineer II, Instrument Plant - Drive Quality Excellence

BD; Maryland; On-site; GBP 57,000 - 91,000; Full time

Job summary

BD is seeking a Quality Engineer II to ensure compliance with ISO and regulatory requirements across the product lifecycle, from design through manufacturing and post-market activities.

You will develop Device History Files, generate CTQ indices, and drive continuous improvement using Six Sigma tools while collaborating with R&D, Operations, and suppliers. A background in medical devices and SAP experience are preferred.

Qualifications

• Bachelor's degree in a relevant field (Biological Sciences, Chemistry, Regulatory Affairs) and 2 years’ experience in QA/QC or investigations.
• Experience in a medical device or pharmaceutical manufacturing facility.
• Experience with SAP transactions.

Responsibilities

• Maintain ISO and regulatory requirements across the product lifecycle from design to manufacturing and customer complaints.
• Develop and maintain Device History Files in full regulatory compliance.
• Generate CTQ indices and provide actionable recommendations for projects, operations, and suppliers.
• Support seamless integration of new products into Manufacturing and Operations.
• Ensure BD regulatory policies and facilities meet applicable requirements.
• Mentor others in Quality Systems and procedures.

Skills

Quality assurance

Regulatory knowledge

Six Sigma

FMEA

Excel

Audit experience

Design control

Data analysis

Education

Bachelor's degree

Tools

SAP

Job description

BD is seeking a Quality Engineer II to ensure compliance with ISO and regulatory requirements across the product lifecycle, from design through manufacturing and post-market activities.

You will develop Device History Files, generate CTQ indices, and drive continuous improvement using Six Sigma tools while collaborating with R&D, Operations, and suppliers. A background in medical devices and SAP experience are preferred.