Senior Design Quality Engineer: Shape Healthcare Innovation

Becton Dickinson; Covington (GA); On-site; USD 90,000 - 140,000; Full time

Job summary

Becton Dickinson is seeking a Senior Quality Engineer to own Quality Assurance, Document Control and Design Control within a product line. You'll interface with Engineering, Operations and suppliers to ensure compliance and robust product quality.

The role emphasizes CAPA, DHF development, validation, and risk management, with leadership in cross-functional teams and mentoring of quality professionals.

Qualifications

• BS/MS Engineering (BME, EE or ME) required.
• 5 years of experience in FDA-regulated environment.
• 3 years of product design experience.
• 2 years of Quality Engineering experience in a regulated environment.

Responsibilities

• Serve as Quality representative on cross-functional project teams and apply Design Control to product/process changes.
• Lead QA leadership and guidance within project teams and the Quality organization.
• Author, review and approve Quality System documentation, including CAPAs and audit reports.
• Develop, review and approve DHFs and other design control deliverables.
• Create and approve validation protocols and reports for products, processes, software, and stability studies.
• Lead risk management activities including FMEA/FMECA/FTA.

Skills

Detail oriented

Regulatory knowledge

Statistical analysis

Supplier quality

Education

BS/MS Engineering (BME/EE/ME)

Job description

Becton Dickinson is seeking a Senior Quality Engineer to own Quality Assurance, Document Control and Design Control within a product line. You'll interface with Engineering, Operations and suppliers to ensure compliance and robust product quality.

The role emphasizes CAPA, DHF development, validation, and risk management, with leadership in cross-functional teams and mentoring of quality professionals.