Senior Quality Systems Engineer Medical Devices Compliance

Abbott (abbottcareers2 board); United States; On-site; USD 90,000 - 150,000; Full time

Job summary

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, and manufacturing.

You will lead data-driven quality initiatives, collaborate with cross-functional teams, and ensure compliance with FDA regulations and ISO standards, while mentoring junior engineers in a fast-paced environment.

Qualifications

• Bachelor's in electrical or technical field required or equivalent combination of education and work experience.
• Minimum 4 years experience in quality systems.
• Masters degree preferred.
• Detailed knowledge of FDA, GMP, and ISO 13485.
• Demonstrated project management and leadership skills across multi-department teams.

Responsibilities

• Provide Quality System Body of Knowledge support to 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 all levels of management and stakeholders; escalate issues timely.
• Ensure compliance with ISO 13485, 21CFR 820 and other regulations; support interpretation and gap analysis.
• Lead improvements using Lean Six Sigma and other quality tools to reduce variance and improve processes.
• Mentor CAPA engineers and support cross-functional teams in quality disciplines.

Skills

Leadership

Project management

Problem solving

Communication

Education

Bachelor's in electrical or technical field

Master's degree

Tools

Lean Six Sigma

Six Sigma

Regulatory knowledge (FDA, GMP, ISO 13485)

Job description

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, and manufacturing.

You will lead data-driven quality initiatives, collaborate with cross-functional teams, and ensure compliance with FDA regulations and ISO standards, while mentoring junior engineers in a fast-paced environment.