Senior Quality Systems Engineer - Medical Devices (ISO 13485)

Abbott; United States; Presencial; USD 110.000 - 160.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Free medical coverage in HIP PPO next-

Excellent retirement savings with high

Tuition reimbursement and FreeU ed.

ASQ/CQE/CQA certifications preferred

Descripción de la vacante

Abbott in Dallas, TX is seeking a Senior Engineer Quality Systems to develop and maintain quality systems across the division, supporting commercialized products, new development, manufacturing, and compliance.

You will lead quality data analysis, drive process improvements with Lean Six Sigma tools, mentor CAPA engineers, ensure ISO 13485 and 21 CFR 820 adherence, and collaborate with cross-functional teams.

Formación

• Must have a bachelor’s degree in electrical or technical field and at least 4 years of relevant experience.
• Masters degree is a plus and can strengthen candidacy.

Responsabilidades

• Provide Quality System Body of Knowledge support to the division and organization.
• Collect and analyze quality data for monthly metrics and data-driven recommendations.
• Investigate, and resolve quality system nonconformances identified in audits.
• Communicate effectively with management and stakeholders; escalate issues timely.
• Ensure ISO 13485 and 21 CFR 820 compliance; support interpretation of regulations and gap analysis.

Conocimientos

Quality systems

Regulatory compliance

Project management

Lean Six Sigma

CAPA

Cross-functional collaboration

Educación

Bachelor’s in electrical/technical field

Master’s degree (plus)

Descripción del empleo

Abbott in Dallas, TX is seeking a Senior Engineer Quality Systems to develop and maintain quality systems across the division, supporting commercialized products, new development, manufacturing, and compliance.

You will lead quality data analysis, drive process improvements with Lean Six Sigma tools, mentor CAPA engineers, ensure ISO 13485 and 21 CFR 820 adherence, and collaborate with cross-functional teams.