Senior Quality Engineer

Responsibilities

• Identify manufacturing process defects, including scrap, nonconforming material, and customer complaints.
• Lead root cause investigations for complex quality issues and implement corrective and preventive actions (CAPA).
• Manage quality issues of moderate to high complexity with minimal oversight, ensuring prompt communication to management.
• Lead cross-functional line support teams to perform triage, containment, and escalation processes.
• Support internal and external audits and maintain product risk analyses and FMEAs.
• Utilize process monitoring tools and statistical process control (SPC) to reduce process variation.
• Drive product and process improvement efforts by analyzing quality metric data.
• Write protocols and reports to support engineering studies and validations.

Requirements

• Bachelor's degree in engineering.
• Minimum 5 years of experience in Quality and/or Compliance.
• Knowledge of applicable US and non-US medical device regulations.
• Proficiency in Quality Engineering principles and application.
• Excellent written, verbal, and interpersonal communication skills in both Spanish and English.
• Proficiency with Microsoft Office and digital tools.
• Ability to lead cross-functional teams and evaluate complex processes.

Preferred Qualifications

• Experience within the medical device industry.

Benefits

• Health Insurance (starting on Day 1).
• Savings Plan (401K) with company match.
• Life insurance for employees and dependents.
• Short Term and Long Term Disability.
• Education Assistance and Employee Assistance Program.
• Paid vacation, sick, and personal days.

About the Company

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.