Quality Engineer

Abbott • Houston, TX

130d • Onsite

About The Position

This position works out of our Houston, TX location in the Abbott Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. THIS IS AN ONSITE DAILY REQUIRED POSITION.

Requirements

• Bachelors Degree Engineering or Technical Field.
• 2+ years Engineering experience and demonstrated use of Quality tools/methodologies.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
• Solid communication and interpersonal skills.
• Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
• Advanced computer skills, including statistical/data analysis and report writing skills.
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.

Nice To Haves

• Prior medical device experience preferred.
• ASQ CQE or other certifications preferred.
• Experience working in a broader enterprise/cross-division business unit model preferred.

Responsibilities

• Identify and implement effective process control systems to support the qualification and on-going manufacturing of products in compliance with FDA 21 CFR Part 820/ISO 13485 requirements
• Lead implementation of quality assurance processes, process controls, and CAPA systems in alignment with regulatory and internal requirements
• Assist in the development and execution of business systems that effectively identify, escalate, and resolve quality issues within a regulated framework
• Apply structured problem-solving methodologies (e.g., DMAIC, root cause analysis) to investigate and resolve quality issues
• Design and conduct experiments to support process validation, optimization, and continuous improvement
• Develop and approve validation documentation including protocols and reports (IQ/OQ/PQ, TMV where applicable)
• Lead process control and monitoring of Critical-to-Quality (CTQ) attributes and specifications
• Lead and implement continuous improvement initiatives using Lean Manufacturing and Six Sigma methodologies
• Lead nonconformance investigations, including NCR, CAPA, and complaint-related analysis, ensuring timely closure and effectiveness verification
• Participate as a core team member representing Quality in cross-functional product transfer and sustaining teams
• Lead and maintain risk management activities in accordance with ISO 14971, including hazard analysis, risk assessment, and risk control verification
• Work with Microbiology and Manufacturing to ensure compliance with environmental monitoring, contamination control, and sterilization requirements where applicable

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

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