Senior Medical Device Design Quality Engineer

BD; Covington (GA); On-site; USD 90,000 - 120,000; Full time

Job summary

BD is a global medical technology leader seeking a Senior Quality Engineer to own Quality Assurance, Document Control, and Design Control within a product line. You will collaborate with Engineering, Operations, and R&D to ensure compliance and robust quality systems.

The role requires leadership in CAPA, audits, and DHFs while guiding cross‑functional teams through design reviews. Successful candidates will drive risk management activities, conduct investigations, and oversee validation efforts

Qualifications

• BS/MS Engineering in a relevant field (BME/EE/ME) required.
• Minimum 5 years of experience in an FDA-regulated environment.
• At least 2 years of Quality Engineering in a regulated setting.
• Product design experience of at least 3 years.

Responsibilities

• Serve as Quality representative on cross‑functional project teams to apply Design Control to changes and new development.
• Provide QA leadership and guidance within project teams and the QA organization.
• Author, review, and approve Quality System documents (CAPAs, audit reports, quality records).
• Develop and approve DHFs and other design control deliverables.
• Create, review, and approve validation protocols and reports for products, processes, software, and stability studies.

Skills

Quality engineering

Regulatory knowledge

Statistical analysis

Documentation practices

Education

BS/MS Engineering (BME or EE or ME)

Tools

CAPA system

DHFs & Design History Files

Risk assessment (FMEA/FTA)

Job description

BD is a global medical technology leader seeking a Senior Quality Engineer to own Quality Assurance, Document Control, and Design Control within a product line. You will collaborate with Engineering, Operations, and R&D to ensure compliance and robust quality systems.

The role requires leadership in CAPA, audits, and DHFs while guiding cross‑functional teams through design reviews. Successful candidates will drive risk management activities, conduct investigations, and oversee validation efforts