Quality Engineer II: Design Control & Regulatory QA

Regulatory Jobs; Covington (GA); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

BD, a global medtech leader, seeks a Quality Engineer to own QA, document control, and design control within a product line. You’ll partner with Manufacturing, R&D, and Product Development to ensure compliance and drive quality improvements.

Responsibilities include leading CAPAs, approving DHFs, validating processes, managing risk documentation (FMEA, FMECA, FTA), and auditing internal and supplier quality systems. Travel up to 15% is required.

Formación

• Bachelor's degree in Engineering (BME or EE) required.
• At least 2 years Quality Engineering in a regulated environment.
• Ability to travel internationally up to 15%.

Responsabilidades

• Serve as Quality representative on cross-functional project teams.
• Provide QA leadership to project teams and the broader QA organization.
• Develop, review, and approve QA documentation, including CAPAs, audit reports, and related records.
• Create, review, and approve Design History Files (DHFs) and supporting design documentation.
• Develop, review, and approve validation protocols and reports (process, product, stability).
• Create, review, and approve risk management documentation (FMEA, FMECA, FTA).
• Investigate product and process nonconformances and lead CAPA activities.
• Conduct internal and supplier quality audits to ensure compliance.
• Review and investigate customer complaints and ensure timely resolution.
• Monitor, analyze, and trend quality metrics to identify improvements.
• Partner with manufacturing sites to support quality objectives and continuous improvement.
• Chair Design Review activities.

Conocimientos

Quality engineering

CAPA management

Risk management

Regulatory knowledge

Statistical analysis

Document control

Cross-functional teamwork

Educación

Bachelor's in Engineering

Master's in Engineering

ASQ Certification

Descripción del empleo

BD, a global medtech leader, seeks a Quality Engineer to own QA, document control, and design control within a product line. You’ll partner with Manufacturing, R&D, and Product Development to ensure compliance and drive quality improvements.

Responsibilities include leading CAPAs, approving DHFs, validating processes, managing risk documentation (FMEA, FMECA, FTA), and auditing internal and supplier quality systems. Travel up to 15% is required.