Senior Quality Engineer (In Vitro Diagnostics)

Location: Cambridge, MA, United States; US and Puerto Rico residents only

Salary: $133,500–$192,833 per year

Company

hirify.global is an R&D-driven biopharmaceutical company developing medicines, vaccines, and healthcare solutions through science, digital technology, and AI-driven innovation.

What you will do

• Design and implement a fit-for-purpose IVD quality management system aligned with ISO 13485, EU IVDR, MDSAP, and applicable FDA requirements.
• Provide quality leadership across IVD development, analytical validation, clinical performance evaluation, regulatory submissions, commercialization, and lifecycle management.
• Oversee design controls, risk management, technical documentation, Performance Evaluation Reports, DHFs, Technical Files, labeling, and regulatory traceability.
• Establish quality frameworks for laboratories, CROs, diagnostic partners, suppliers, and third-party development activities.
• Manage nonconformances, deviations, CAPA, complaints, vigilance reporting, post-market surveillance, and PMPF strategies.
• Partner with R&D, Regulatory Affairs, Clinical, Manufacturing, and Laboratory Operations to support compliant IVD commercialization.

Requirements

• Bachelor’s degree in engineering, biomedical engineering, biochemistry, molecular biology, analytical chemistry, or a related field.
• 10+ years of quality management experience in IVD or closely related diagnostic fields.
• In-depth knowledge of ISO 13485, EU IVDR, FDA 21 CFR Part 820 and Part 809, MDSAP, GxP, ISO 18113, ISO 15189, and CLSI guidelines.
• Experience with IVD design controls, DHF and Technical File management, analytical performance studies, process validation, method validation, and design transfer.
• Experience with clinical and performance studies, laboratory quality systems, supplier quality, complaint handling, MDR or vigilance reporting, and post-market surveillance.
• Knowledge of ISO 14971, IEC 62304, IEC 62366-1, SaMD quality, cybersecurity, and AI/ML-based IVD products.

Nice to have

• Advanced degree such as an MS or PhD.
• Strong leadership experience and experience building or transforming QMS in a developing organization.
• Manufacturing operations experience and knowledge of drug-device combination products.

Culture & Benefits

• Supportive, future-focused environment centered on science and innovation.
• Career development opportunities through promotion and lateral mobility.
• Company rewards and employee benefit programs.
• Healthcare, prevention, wellness, and family benefits, including at least 14 weeks of gender-neutral parental leave.
• Opportunity to contribute to digital, data, AI-driven innovation, and global medicine and vaccine delivery.