Quality Engineer - Process (Medical Devices)

Location: Aibonito, Puerto Rico; onsite role

Company

hirify.global develops healthcare products and solutions with a mission to save and sustain lives.

What you will do

• Provide quality guidance and technical support for manufacturing processes, process control, and compliance with internal and external regulations.
• Lead root cause, corrective and preventive action, non-conformance, customer complaint, and quality risk investigations.
• Participate in equipment, subassembly, software, and database validation protocols.
• Manage continuous process verification, quality programs, sampling plans, quality data reviews, and defect-per-million analysis.
• Lead quality activities for sterilization and parametric release programs, including alarm evaluation and product disposition.
• Participate in internal and external audits, multidisciplinary meetings, process modifications, and special projects.

Requirements

• Bachelor’s degree in engineering.
• At least one year of experience and knowledge of statistical applications and methods.
• Knowledge of engineering and management practices, computer systems, technical reporting, GMP, GDP, FDA, ISO, and other regulatory requirements.
• Fully bilingual in English and Spanish.
• Ability to work with personnel at all levels, manage multiple tasks, work with minimal supervision, and meet project milestones.
• Willingness to travel occasionally and perform light physical work, including walking, standing, and handling up to 20 pounds occasionally.

Culture & Benefits

• Work in a collaborative, accountable healthcare manufacturing environment focused on quality and patient impact.
• Employee benefits for eligible roles include medical and dental coverage, life and disability insurance, retirement savings, employee stock purchase, educational assistance, paid time off, and parental leave.
• Additional benefits may include commuting assistance, employee discounts, employee assistance, and childcare support.