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 appropriate 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, determine containment, and initiate escalation processes as required.
• Develop product quality plans, risk analyses, and FMEAs, providing direction for setting product specifications.
• Utilize process monitoring tools and SPC to understand process shifts and reduce variation.
• Support internal and external audits and implement complex changes through the change management system.
• 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, preferably within the medical device industry.
• Knowledge of applicable US and non-US medical device regulations.
• Proficiency in Quality Engineering principles and application.
• Fluent in both Spanish and English (written and verbal).
• Proficiency with Microsoft Office and digital tools.
• Ability to lead cross-functional teams and interact effectively with all levels of the organization.

Benefits

• Health Insurance (starting on Day 1 of employment).
• 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 creates breakthrough science to improve people’s health. Our portfolio of life-changing technologies spans diagnostics, medical devices, nutritionals, and branded generic medicines, serving people in more than 160 countries.