Quality Engineer (Medical Devices)

Location: Aibonito, Puerto Rico

Company

Medical technology operations focused on developing and manufacturing products that support healthcare delivery and help sustain lives.

What you will do

• Ensure compliance with quality-system, manufacturing-process, GMP, FDA, ISO, and other regulatory requirements.
• Provide technical quality support for process control, product specifications, procedures, special tests, and process or technology modifications.
• Participate in equipment, subassembly, software, database, and process validation protocols.
• Lead root-cause investigations, non-conformance investigations, corrective and preventive actions, customer-complaint evaluations, and continuous improvement projects.
• Manage quality programs including Continuous Process Verification, sampling plans, quality data reviews, defect-per-million analysis, and internal and external audits.
• Support sterilization programs, evaluate sterilization alarms, approve product dispositions, and coordinate with multidisciplinary teams to prevent product-release delays.

Requirements

• Bachelor’s degree in Engineering.
• At least one year of experience and knowledge of statistical applications.
• Knowledge of engineering and management practices, statistical methods, computer systems, and technical reporting.
• Working knowledge of Microsoft Office, Outlook, TrackWise, and TcU.
• Fully bilingual in English and Spanish.
• Ability to work independently, manage multiple tasks, communicate across plant levels, and travel occasionally.

Culture & Benefits

• Full-time employment with a collaborative, accountable, and ownership-oriented work environment.
• Work focused on quality, regulatory compliance, and healthcare impact.
• Light physical work involving occasional lifting of up to 20 pounds and regular standing or walking.
• US benefits listed in the posting apply except for Puerto Rico.