Senior Engineer Quality Systems

Abbott • Irving, TX

17h • Onsite

About The Position

The Senior Engineer Quality Systems works in Abbott’s Transfusion Medicine Diagnostics Division in the Dallas, Texas area. The role develops and maintains quality systems and provides quality-system support for commercialized products, new product development, manufacturing, and system compliance. It supports the division’s quality-system body of knowledge, analyzes quality data, investigates audit-related nonconformances, and helps ensure compliance with applicable regulations and standards. The position also identifies and leads opportunities to improve compliance and processes, applies systematic problem-solving and quality tools, supports divisional quality initiatives, and mentors lower-level CAPA engineers. Travel, including international travel, is required; the listed travel expectation is 10% of the time.

Requirements

• Bachelor’s degree in an electrical or technical field, or an equivalent combination of education and work experience.
• At least 4 years of experience.
• Ability to travel, including internationally.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work both as a team member and an individual contributor in a fast-paced, changing environment.

Nice To Haves

• Master’s degree.
• Four to eight years of technical experience.
• Previous Quality experience and demonstrated use of Quality tools or methodologies.
• Detailed knowledge of FDA, GMP, and ISO 13485.
• Demonstrated project management and leadership skills, including leading multi-departmental project teams and resolving quality-system issues effectively and promptly.
• Advanced computer skills, including gap analysis and report writing.
• Medical device experience.
• Six Sigma certification or Lean Manufacturing experience.
• ASQ CQE or CQA certification.
• Experience in a broader enterprise or cross-division business-unit model.

Responsibilities

• Provide Quality System Body of Knowledge support to the division and organization.
• Collect and analyze quality data for monthly metrics and develop data-driven recommendations based on trends.
• Investigate and resolve quality-system nonconformances identified during internal or external audits.
• Communicate with management, peers, and stakeholders, escalating quality issues in a timely manner.
• Support interpretation of applicable regulations, perform gap analyses, and lead activities to implement compliance improvements.
• Use systematic problem-solving methods to identify, prioritize, communicate, and resolve quality issues.
• Apply Lean Six Sigma and other quality tools as appropriate to improve processes, product quality, and process variation.
• Analyze quality audit findings and recommend modifications to products or standards.
• Identify opportunities to improve system compliance and lead implementation activities.
• Participate in or lead teams supporting quality disciplines, decisions, and practices, including representing the Quality System function as a team member.
• Mentor lower-level CAPA engineers.
• Support divisional initiatives related to QMS, EMS, and other regulatory requirements.
• Comply with FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.

Benefits

• Career development opportunities with an international company.
• Potential eligibility for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with a high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit providing an affordable and convenient path to a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior