Quality Engineer I (Medtech)

TL;DR

Quality Engineer I (Medtech): Ensuring product and process quality throughout development, validation, and production readiness for machining and secondary operations with an accent on risk-based validation and regulatory compliance. Focus on leading IQ/OQ/PQ activities, analyzing process capability, and ensuring adherence to GMP, FDA, and ISO standards.

Location: Humacao, Puerto Rico, USA

Company

hirify.global is a global healthcare technology leader dedicated to alleviating pain, restoring health, and extending life through innovative engineering solutions.

What you will do

• Lead and support risk-based validation activities (IQ/OQ/PQ) for machining and selected secondary operations.
• Develop and maintain quality standards and protocols for processing materials into finished products.
• Collaborate with engineering and manufacturing teams to ensure quality standards and equipment readiness for production release.
• Design inspection and testing mechanisms and perform statistical analysis to assess product accuracy.
• Drive compliance with GMP, FDA, and ISO requirements through disciplined documentation and audit readiness.
• Analyze data to identify quality risks and support nonconformance and CAPA activities.

Requirements

• Bachelor's degree in Engineering.
• Unrestricted U.S. work authorization is required (sponsorship is not available for this level).
• Strong knowledge of Process Validation (IQ/OQ/PQ) and risk-based validation approaches.
• Proficiency in risk management tools such as FMEA and hazard analysis.
• Knowledge of statistical methods including SPC and capability analysis.
• Experience with root cause investigation tools such as 5 Why, Fishbone, or DMAIC.

Nice to have

• Degree specifically in Mechanical, Industrial, or Chemical Engineering.
• Familiarity with ISO 13485 and FDA Quality System Regulations.
• Lean Six Sigma Green Belt certification or training.
• Experience with Minitab or equivalent statistical software.
• Basic programming skills in Python or VBA to support process analysis and reporting.

Culture & Benefits

• Competitive salary and flexible benefits package.
• Eligibility for the hirify.global Incentive Plan (MIP) short-term incentive.
• Commitment to healthcare access, equity, and a mission-driven professional environment.
• Opportunity to work in a global company with over 95,000 passionate employees.