Senior Quality Engineer (Medical Devices)

Location: Onsite in Jacksonville, Florida, United States; presence at the manufacturing facility five days per week. Up to 20% travel may be required. Unrestricted U.S. work authorization is required; sponsorship is not available for roles below Principal level.

Salary: $98,400–$147,600 per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies and medical devices used to alleviate pain, restore health, and extend life.

What you will do

• Lead quality engineering activities supporting manufacturing operations, incoming inspection, material acceptance, and product release.
• Partner with Manufacturing, Operations, Supplier Quality, and Engineering to establish and maintain quality standards and inspection requirements.
• Analyze quality data and performance trends using AI, Power BI, and Microsoft Excel to identify process improvements and reduce risk.
• Design and evaluate inspection and testing methods for product and process conformity.
• Investigate complaints, nonconformances, and quality issues; determine root causes and implement corrective and preventive actions.
• Maintain quality documentation and records in compliance with regulatory and internal quality-system requirements.

Requirements

• Bachelor’s degree with 4+ years of quality engineering, manufacturing quality, or related experience; or a master’s degree with 2+ years; or a PhD.
• Knowledge of FDA Quality System Regulation, ISO 13485, ISO 14971, Good Manufacturing Practices, and related standards.
• Experience with quality improvement, CAPA, nonconformance investigations, root-cause analysis, audits, and complaint handling.
• Experience with incoming inspection, product release, quality control, and manufacturing quality systems.
• Proficiency in statistical analysis, process capability, Minitab, Microsoft Excel, and Power BI.
• Knowledge of GD&T and electrical schematics is preferred; ASQ Certified Quality Engineer certification or comparable certification is advantageous.

Nice to have

• Medical device industry experience supporting manufacturing, quality, or regulatory functions.
• Experience leading Lean Manufacturing, Six Sigma, continuous improvement, supplier audits, or internal quality audits.
• ASQ Certified Quality Engineer certification or comparable quality certification.

Culture & Benefits

• Full-time employment at an onsite manufacturing facility.
• Health, dental, vision, life, and disability insurance options.
• Health Savings Account, Flexible Spending Account, dependent daycare account, and tuition assistance.
• 401(k) plan with employer contribution and match, paid time off, paid holidays, and employee stock purchase plan.
• Short-term incentive eligibility and employee assistance resources.