Sr. Operations QA Engineer

The Opportunity

This position works out of our Plano, TX location in the Abbott Neuromodulation business unit. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.

The Senior QA Engineer – Operations Quality plays a critical role in driving product and process excellence across manufacturing operations. This position is responsible for leading quality improvement initiatives, analyzing quality data to identify trends and root causes, and managing cross-functional projects aimed at reducing scrap, improving yield, and enhancing compliance. The ideal candidate is a data-driven problem solver with strong project management skills and a passion for continuous improvement.

What You’ll Work On

Lead and execute quality improvement projects focused on scrap reduction, defect elimination, and process optimization.

Analyze quality data (e.g., nonconformance trends, yield metrics, inspection results) to identify systemic issues and drive corrective actions.

Develop and maintain dashboards and reports to monitor key performance indicators (KPIs) and support decision-making.

Collaborate with Manufacturing, Engineering, and Supply Chain teams to resolve quality issues and implement sustainable solutions.

Support CAPA investigations, root cause analysis, and implementation of robust corrective / preventive actions.

Drive standardization and best practices across inspection, documentation, and quality control processes.

Lead or support validation activities, including protocol development, execution, and documentation.

Ensure compliance with applicable regulatory standards (e.g., ISO 13485, FDA 21 CFR Part 820) and internal quality procedures.

Participate in internal and external audits, including preparation and response to findings.

Mentor junior engineers and quality staff, fostering a culture of technical excellence and continuous improvement.

Required Qualifications

Bachelor’s degree in engineering, Life Sciences, or related field

Minimum 5 years of experience in Quality Assurance or Quality Control within a regulated manufacturing environment

Preferred Qualifications

Advanced degree or certifications (e.g., ASQ, Six Sigma) preferred

Proficiency with data analysis tools (e.g., Excel, Minitab, Power BI, JMP) and electronic QMS systems.

Strong experience in quality data analytics, including statistical analysis, trend identification, and reporting.

Proven track record of leading cross-functional projects and driving measurable improvements.

Solid understanding of quality systems, inspection techniques, and regulatory requirements (ISO 13485, FDA).

Excellent communication, collaboration, and problem-solving skills.