Senior Quality Systems Engineer – Medical Device Compliance

Abbott; Irving (TX); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Free medical coverage in HIP PPO plan

High employer retirement contribution

Tuition reimbursement and education‑up

Recognition as great place to work

Job summary

Abbott in Dallas, TX seeks a Senior Engineer Quality Systems to develop and maintain quality systems for the Diagnostics Division, spanning commercialized products, NPD, and manufacturing, ensuring regulatory compliance and continuous improvement.

You will analyze data, lead CAPAs, and mentor lower-level engineers while collaborating with cross-functional teams to meet quality objectives and regulatory requirements.

Qualifications

• Bachelor’s or higher in electrical or technical field or equivalent.
• Minimum 4 years of experience.

Responsibilities

• Provides Quality System Body of Knowledge support to Division and organization.
• Collect and analyze quality data for monthly metrics and trends.
• Investigates quality system nonconformances and drives CAPA actions.
• Ensure compliance with ISO 13485, 21CFR 820 and other regulations.
• Lead process improvements using Lean Six Sigma where appropriate.
• Mentor CAPA engineers and support regulatory initiatives.

Skills

Quality systems knowledge

Regulatory compliance

Project leadership

Lean Six Sigma

Education

Bachelor’s in electrical or technical field

Minimum 4 years experience

Masters degree a plus

Job description

Abbott in Dallas, TX seeks a Senior Engineer Quality Systems to develop and maintain quality systems for the Diagnostics Division, spanning commercialized products, NPD, and manufacturing, ensuring regulatory compliance and continuous improvement.

You will analyze data, lead CAPAs, and mentor lower-level engineers while collaborating with cross-functional teams to meet quality objectives and regulatory requirements.