Sr Quality Engineer (Medical Devices)

Location: Humacao, Puerto Rico, United States of America. Onsite manufacturing role. Unrestricted U.S. work authorization is required at the time of hire and throughout employment; sponsorship is offered only for Principal-level roles and above.

Company

hirify.global develops healthcare technologies and medical devices used to improve patient care worldwide.

What you will do

• Support quality assurance activities in a regulated manufacturing environment.
• Manage investigations, nonconformances, CAPA, change control, validation deliverables, and risk assessments.
• Develop and maintain quality standards, inspection methods, testing protocols, and process controls.
• Perform quality tests, statistical analysis, process monitoring, and reliability assessments.
• Collaborate with manufacturing, engineering, supplier quality, and operations teams to resolve quality issues and drive continuous improvement.
• Maintain audit-ready documentation and compliance with FDA, ISO, GMP, and internal quality system requirements.

Requirements

• Bachelor’s degree in engineering and at least 4 years of relevant experience, or a master’s degree with at least 2 years of experience, or a PhD with no required experience.
• Experience in engineering, quality, or manufacturing; medical device or FDA/ISO-regulated manufacturing experience is preferred.
• Knowledge of ISO 13485, FDA Quality System Regulation, GMP, nonconformance management, CAPA, document control, change control, and risk management.
• Experience with validation concepts, including URS, SRS, IQ, OQ, PQ, and risk-based validation.
• Experience with structured problem-solving and risk assessment methods such as 5 Whys, Fishbone, FMEA, or fault tree analysis.
• For degrees earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

Nice to have

• Degree in Mechanical, Industrial, or Electrical Engineering.
• Experience with NPI, product transfers, supplier qualification, component qualification, and supplier quality improvement.
• Knowledge of machining, anodizing, packaging, inspection, test methods, or other manufacturing process controls.
• Experience with SPC, capability analysis, DOE, trending, sampling rationale, Minitab, JMP, Excel, Power BI, SAP, or JDE.
• Lean Six Sigma certification or experience using automation, dashboards, VBA, Python, or AI-assisted tools for reporting and process analysis.

Culture & Benefits

• Full-time employment in a purpose-driven healthcare technology organization.
• Competitive compensation and a flexible benefits package.
• Short-term incentive eligibility through the hirify.global Incentive Plan.
• Equal employment opportunity and reasonable accommodations for qualified individuals with disabilities.