Senior Quality Engineer

About the role

This position works out of our Plano, TX location in the Neuromodulation division. 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.

Responsibilities

• Lead efforts to reduce and control manufacturing process defects (scrap, nonconforming material, customer complaints) through root cause analysis and corrective/preventive actions.
• Own and drive Nonconforming Material Report (NCMR) creation, revision, and closure, ensuring accuracy and audit readiness.
• May initiate product stops and define release criteria aligned to quality and risk requirements.
• Develop, implement, and maintain product and process quality plans, specifications, control plans, and FMEAs.
• Establish and improve process monitoring systems by reducing variation and preventing defect recurrence.
• Collect, analyze, and trend quality data and translate findings into actionable improvements.
• Directly supervise five (5) Quality Control Inspectors, providing daily oversight, coaching, and performance management.
• Support and guide other Quality Engineers on the production line through dotted-line leadership.
• Demonstrate strong, timely decision-making that balances quality, compliance, and production requirements.
• Build a culture of accountability, ownership, and continuous improvement.
• Effectively manage relationships with upstream and downstream partners and leadership.
• Develop and deliver quality tools, procedures, and training materials.
• Ensure ongoing compliance with regulatory, customer, and internal quality system requirements.
• Support internal and external audits and ensure timely closure of corrective actions.
• Participate in defining department goals and project objectives.
• Influence middle management on technical and business solutions.
• Demonstrate readiness for expanded leadership scope as a future successor role.

Requirements

• Bachelor’s degree in a related field or equivalent combination of education and experience required.
• Minimum five (5) years of progressively responsible experience in manufacturing and/or regulated quality environments.
• Demonstrated understanding of cross-functional business operations and quality systems.
• Proven ability to solve complex problems using data analysis and sound judgment.

Qualifications

• Master’s degree preferred
• 3 years supervisory experience
• FDA regulatory body auditing experience

Skills

• Quality and Process Engineering leadership
• Root cause analysis and corrective/preventive actions
• Nonconforming Material Report (NCMR) creation, revision, and closure
• Product stops and release criteria definition
• Product and process quality plans, specifications, control plans, and FMEAs
• Process monitoring systems establishment and improvement
• Quality data collection, analysis, and trend translation
• Supervisory and people leadership
• Strong decision-making balancing quality, compliance, and production requirements
• Culture building of accountability, ownership, and continuous improvement
• Relationship management with upstream and downstream partners and leadership
• Quality tools, procedures, and training materials development
• Regulatory, customer, and internal quality system compliance
• Audits support and corrective actions closure
• Department goals and project objectives participation
• Technical and business solutions influence
• Leadership scope readiness for expansion

Benefits

• Career development with an international company
• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan
• Excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit
• Company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune
• Company recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists

Pay

The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted.

Schedule

Not specified

Benefits

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives : www.abbottbenefits.com

Contact

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