Sr Quality Engineer (Medical Devices)

Location: Juncos, Puerto Rico, United States of America; onsite work model

Company

hirify.global develops healthcare technologies intended to alleviate pain, restore health, and extend life, serving patients across more than 150 countries.

What you will do

• Lead complex CAPA, NCMR, and root cause investigations to identify systemic issues and implement sustainable corrective actions.
• Partner with engineering and manufacturing teams to establish, maintain, and improve product and process quality standards.
• Develop quality protocols, procedures, inspection strategies, and testing methods for manufacturing processes and products.
• Apply SPC, trend analysis, Minitab, and other statistical methods to monitor performance, identify risks, and support data-based decisions.
• Assess nonconformances and ensure corrective actions meet reliability, compliance, and quality requirements.
• Mentor junior Quality Engineers and promote continuous improvement across the site.

Requirements

• Bachelor’s degree in Engineering with at least 4 years of relevant experience, or a Master’s degree with at least 2 years of relevant experience, or a PhD.
• Experience supporting quality engineering activities in a regulated manufacturing environment.
• Experience conducting investigations, assessing nonconformances, and implementing corrective actions.
• Experience using statistical methods and data analysis to evaluate product or process performance.
• Ability to collaborate with engineering, manufacturing, and quality teams.
• Unrestricted U.S. work authorization is required at the time of hire and throughout employment; sponsorship is not available for roles below Principal level.

Nice to have

• Advanced knowledge of GMP, FDA regulations, ISO 13485, and Quality System Regulations.
• Expertise with Minitab, SPC, trend analysis, and process capability assessments.
• Lean Six Sigma Green Belt or Black Belt certification.
• Experience with manufacturing process controls, inspection optimization, digital quality systems, and quality data analytics tools.

Culture & Benefits

• Purpose-driven work focused on improving healthcare and patient outcomes.
• Competitive compensation and a flexible benefits package.
• Eligibility for the hirify.global Incentive Plan short-term incentive.
• Reasonable accommodations are available for qualified individuals with disabilities.