Senior Quality Engineer, Product Development & Risk

Abbott; Plano (TX); On-site; USD 87,000 - 173,000; Full time

Benefits offered by this job

HIP PPO medical plan

Retirement savings plan with high-empl

Tuition reimbursement

FreeU education benefit

Recognition as a great place to work

Job summary

Abbott is seeking a Senior Development Quality Engineer to join the Neuromodulation team in Plano, TX. You will lead quality activities across development projects, drive risk management integration, and collaborate with Clinical, Regulatory, and R&D to ensure patient safety and regulatory compliance.

The role demands strong root-cause analysis, data-driven decision making, and the ability to produce inspection-ready DHF documentation while aligning with ISO 14971, FDA QMSR, and EU MDR

Qualifications

• Bachelor's degree in Engineering or technical field required.
• 5+ years of quality engineering experience with quality tools/methodologies.
• Strong root-cause analysis and data analysis skills.
• Excellent verbal and written communication at multiple levels.

Responsibilities

• Promote and assure quality in product development projects.
• Lead risk management integration into development, sustaining engineering, supplier changes, and post-market activities per ISO 14971 and FDA QMSR.
• Collaborate with Clinical, Regulatory, R&D, and Post-Market teams to evaluate risk-based evidence.
• Develop objective, verifiable requirements addressing hazards and risk controls.
• Ensure complete DHF documentation with traceability from hazards to verification and post-market performance.

Skills

Quality engineering

Root cause analysis

Data analysis

Communication skills

Education

Bachelor's degree in Engineering or technical field

Master's degree preferred

Job description

Abbott is seeking a Senior Development Quality Engineer to join the Neuromodulation team in Plano, TX. You will lead quality activities across development projects, drive risk management integration, and collaborate with Clinical, Regulatory, and R&D to ensure patient safety and regulatory compliance.

The role demands strong root-cause analysis, data-driven decision making, and the ability to produce inspection-ready DHF documentation while aligning with ISO 14971, FDA QMSR, and EU MDR