Quality Engineer I (Medtech)

TL;DR

Quality Engineer I (Medtech): Supporting product development and manufacturing lifecycle activities by ensuring compliance with quality systems and regulatory requirements with an accent on data-driven root cause analysis and process validation. Focus on maintaining quality standards, executing corrective and preventive actions, and collaborating cross-functionally to ensure product reliability.

Location: Must be based in Humacao, Puerto Rico, United States

Company

hirify.global is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life for millions of patients worldwide.

What you will do

• Develop and maintain quality standards and protocols for processing materials into finished products.
• Collaborate with engineering and manufacturing teams to ensure adherence to quality standards.
• Design inspection and testing mechanisms to evaluate product precision and accuracy.
• Perform statistical analysis to assess product quality and determine root causes for non-conformances.
• Ensure corrective measures meet reliability standards and maintain compliant documentation.
• Support audits, validations, and risk management activities across the product lifecycle.

Requirements

• Baccalaureate degree in Engineering required.
• Must possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
• 0 years of relevant experience.
• Strong critical thinking and problem-solving skills.
• Ability to work cross-functionally in a manufacturing environment.

Nice to have

• Understanding of QMS (ISO 13485, FDA QSR) and CAPA processes.
• Experience with statistical software like Minitab.
• Knowledge of Six Sigma or Lean methodologies.
• Basic programming or scripting skills (Python, VBA) for data automation.
• Experience with Manufacturing Execution Systems (MES).

Culture & Benefits

• Competitive salary and comprehensive benefits package.
• Participation in the hirify.global Incentive Plan (MIP).
• Commitment to equal employment opportunity and inclusive workplace culture.
• Opportunities for professional growth within a global healthcare technology leader.