Sr Quality Engineer (Medical Devices)

Location: Humacao, Puerto Rico, United States of America

Company

hirify.global develops healthcare technologies intended to alleviate pain, restore health, and extend life.

What you will do

• Support quality assurance activities in a regulated manufacturing environment.
• Manage investigations, nonconformances, CAPA, change control, validation deliverables, risk assessments, process monitoring, and audit readiness.
• Develop and maintain quality standards and protocols for materials, products, and production processes.
• Design inspection and testing methods and equipment, conduct quality tests, and apply statistical analysis.
• Collaborate with manufacturing, engineering, supplier quality, and operations teams to resolve quality issues and drive continuous improvement.
• Ensure corrective actions and technical documentation meet reliability, regulatory, and 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 relevant experience, or a PhD with no prior experience required.
• Experience in engineering, quality, or manufacturing.
• Knowledge of regulated manufacturing environments, including FDA, ISO, and GMP requirements.
• Knowledge of quality systems, including ISO 13485, FDA Quality System Regulation, nonconformance management, CAPA, document control, change control, and risk management.
• Unrestricted U.S. work authorization is required at the time of hire and throughout employment; sponsorship is not available for this role.
• 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 medical device manufacturing, NPI, product transfers, supplier qualification, and supplier quality improvement.
• Knowledge of validation concepts, including URS, SRS, IQ, OQ, PQ, and risk-based validation.
• Experience with manufacturing processes, structured problem-solving, FMEA, SPC, capability analysis, DOE, and process monitoring.
• Experience with Minitab, JMP, Excel, Power BI, PowerPoint, SAP, JDE, Factory Works, VBA, Python, or similar tools; Lean Six Sigma certification is preferred.

Culture & Benefits

• Mission-driven work focused on improving patient health through medical technology.
• 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.