Regional Lead Quality Engineer (Medical Devices)

Location: Waltham, Massachusetts, or King of Prussia, Pennsylvania, United States. Periodic domestic and international travel is required.

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

Company

hirify.global is a global biotherapeutics company developing and delivering therapies across immunology, hematology, cardiovascular, metabolic, respiratory, and transplant areas.

What you will do

• Lead quality guidance and oversight for combination product and medical device development projects.
• Ensure design development follows Design Controls, risk analysis, statistical analysis, sampling plans, and applicable regulatory requirements.
• Oversee external medical device development and manufacturing partners, including audits, quality agreements, and vendor performance.
• Report quality-system and project risks to management and stakeholders.
• Drive compliant quality-system implementation and process improvements, including SOPs, work instructions, forms, and training.
• Maintain combination-product quality databases and use Six Sigma problem-solving to resolve issues.

Requirements

• Bachelor’s degree in mechanical engineering, biomedical engineering, life sciences, or a relevant discipline.
• At least 5 years of experience in quality, packaging, engineering, or manufacturing within medical devices or combination products; pharmaceutical, biotech, or medtech experience may also be considered.
• Working knowledge of 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, EU MDR, FDA guidance, and compliant quality management systems.
• At least 2 years of practical experience in medical device R&D quality, including design controls, requirements, risk management, FMEA, V&V, usability studies, DHFs, and design transfer.
• 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.

Culture & Benefits

• Work within a global biotherapeutics organization serving patients in more than 100 countries.
• Benefits are provided through CSL’s employee well-being programs.
• Inclusive culture focused on belonging, curiosity, empathy, and collaboration.
• Periodic domestic and international travel offers collaboration across global functions and manufacturing sites.