Quality Engineering S

Job Title

Quality Engineer

Position Overview

This position works out of our Houston, TX location in the Abbott Vascular Division. It focuses on developing and maintaining quality engineering methodologies and providing support during manufacturing and site transfer activities. This is an onsite daily required position.

Responsibilities

Identify and implement effective process control systems to support the qualification and ongoing 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.

Travel Requirements

Required travel: 10‑15%. For the first 6‑12 months travel could be up to 50% including travel outside of the United States.

Required Education

Bachelor's degree in Engineering or a technical field.

Required Experience and Qualifications

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 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.

Prior medical device experience preferred. Experience implementing various product and process improvement methodologies (e.g., Six Sigma, Lean Manufacturing).

ASQ CQE or other certifications preferred.

Experience working in a broader enterprise/cross‑division business unit model preferred.

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 communication with ability to effectively communicate at multiple levels in the organization.

Multitasks, prioritizes and meets deadlines in a timely manner.

Strong organizational and follow‑up skills, as well as attention to detail.

Compensation

The base pay for this position is $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted.

Equal Opportunity

Abbott is an Equal Opportunity Employer, committed to employee diversity.

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