Senior Engineer Quality Systems

Abbott • Irving, TX

2d • $78,000 - $156,000 • Onsite

About The Position

The Senior Engineer Quality Systems works in Abbott’s Transfusion Medicine, Diagnostics Division, at its Dallas, Texas location. The role develops and maintains quality systems and provides quality-system support across the division, including commercialized products, new product development, manufacturing, and system compliance. The position supports the division’s Quality Management Systems, Environmental Management Systems, and other regulatory requirements.

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 part of a team and as an individual contributor in a fast-paced, changing environment.

Nice To Haves

• Master’s degree.
• 4–8 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.
• Previous medical-device experience.
• Six Sigma certification or Lean Manufacturing experience.
• ASQ CQE or CQA certification.
• Experience working 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 make data-driven recommendations based on trends.
• Investigate and resolve quality-system nonconformances identified during internal or external audits.
• Communicate effectively with management, peers, and stakeholders, escalating quality issues in a timely manner.
• Support interpretation of regulations, perform gap analyses, and lead activities to improve compliance with ISO 13485, 21 CFR 820, and other applicable regulations and standards.
• Use systematic problem-solving methods to identify, prioritize, communicate, and resolve quality issues.
• Use Lean Six Sigma and other quality tools, as appropriate, to improve processes, product quality, and process variation, and to identify opportunities to improve divisional quality-system compliance.
• Analyze quality audit findings and recommend modifications to products or standards; proactively identify compliance improvements 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 through 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 for pursuing a bachelor’s degree.

What This Job Offers

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