Regional Lead Quality Engineer (Medical Devices)

Location: Waltham, Massachusetts, United States; periodic domestic and international travel required.

Salary: $143,000–$169,000 annual base salary, with potential incentive compensation and equity.

Company

hirify.global is a global biotechnology company developing and delivering biotherapeutics, vaccines, and therapies for patients in more than 100 countries.

What you will do

• Provide quality guidance and oversight for combination product development projects throughout the product lifecycle.
• Ensure design development activities follow Design Controls and applicable FDA, EU MDR, ISO, and other regulatory requirements.
• Apply risk analysis, statistical data analysis, sampling plans, and other quality engineering techniques.
• Assess external medical device development and manufacturing partners through audits, agreements, and performance monitoring.
• Improve quality systems, update SOPs, work instructions, and forms, and deliver training on revised processes.
• Maintain combination product quality databases, report progress, escalate risks, and resolve issues using Six Sigma methods.

Requirements

• Bachelor’s degree in mechanical engineering, biomedical engineering, life sciences, or a related discipline.
• At least 5 years of experience in quality, packaging, engineering, or manufacturing within medical devices or combination products.
• At least 2 years of practical experience in medical device R&D quality, including design controls, risk management, V&V, usability studies, DHFs, and design transfer.
• Working knowledge of 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, EU MDR, FDA guidance, and compliant QMS practices.
• Strong communication, collaboration, stakeholder influence, problem-solving, planning, and organizational skills.

Nice to have

• Experience developing drug-delivery combination products.
• Experience with embedded software, mobile or web applications, and connected health solutions.
• Background in pharmaceutical, biotech, medtech, or related industries.

Culture & Benefits

• Work with global functions, manufacturing sites, and external development partners.
• Periodic domestic and international travel.
• Potential incentive compensation and equity in addition to base salary.
• Inclusive workplace focused on belonging, curiosity, empathy, and collaboration.