Associate Quality Engineer (Combination Products)

Location: Waltham, Massachusetts, United States

Salary: $94,000–$111,000 annual base salary

Company

hirify.global is a global biotherapeutics company developing and delivering therapies, vaccines, and other lifesaving products in more than 100 countries.

What you will do

• Serve as a Quality Engineer on combination product development projects.
• Support Design Control activities, risk management, document reviews, verification and validation planning, change management, and DHF maintenance.
• Help ensure development work meets FDA, EU MDR, and other global regulatory requirements.
• Support oversight of external development and manufacturing partners through audits, quality agreement reviews, and vendor performance monitoring.
• Maintain and improve combination product quality systems, including SOPs, work instructions, forms, training, and quality databases.
• Support investigations, CAPAs, nonconformance management, change controls, internal audits, and inspection readiness.

Requirements

• Bachelor’s degree in mechanical engineering, biomedical engineering, life sciences, or a related discipline.
• At least three years of experience in quality, engineering, manufacturing, or a related technical role in medical devices, pharmaceuticals, biotechnology, medtech, or combination products.
• Working knowledge of 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and EU MDR.
• Familiarity with Design Controls, risk management, verification and validation, and design transfer.
• Strong communication, collaboration, organization, planning, analytical, and problem-solving skills.
• Ability to work independently on routine assignments and seek guidance on complex issues.

Nice to have

• Experience with combination products or drug delivery devices.

Culture & Benefits

• Work with global teams and manufacturing sites supporting products for patients worldwide.
• Benefits information is provided by CSL as part of the employment package.
• Inclusive workplace focused on belonging, curiosity, empathy, and collaboration.
• Additional compensation may include incentive compensation and equity.