Senior Quality Director (Medical Devices)

Location: Hybrid work schedule with onsite work in Waltham, Massachusetts, United States

Salary: $220,000–$300,000 per year

Company

hirify.global develops medical diagnostic and in vitro diagnostic instrumentation, biotechnology solutions, and osmolality testing products for clinical and biopharmaceutical markets.

What you will do

• Lead corporate quality and compliance activities across global manufacturing sites.
• Support and lead FDA, TÜV, partner, customer, regulatory, and internal audits.
• Manage CAPAs, NIRs, failure investigations, shipping holds, NCMRs, and MRB approvals.
• Oversee validation, quality training, quality plans, metrics, KPIs, and quality system improvements.
• Manage supplier, customer, and partner qualification activities, including SCARs, quality surveys, and quality agreements.
• Provide quality leadership to subsidiaries and collaborate with R&D, Manufacturing, Engineering, Purchasing, Supplier Quality Engineering, and Technical Support.

Requirements

• Bachelor’s degree in science or a technical discipline, or 10+ years of quality assurance experience in medical devices or diagnostics.
• 12+ years of medical diagnostic or medical device experience managing a quality program.
• 12+ years of quality team management experience.
• Working knowledge of GMP and experience applying root cause analysis and structured problem-solving methods.
• Experience performing and leading internal and external audits, driving process improvements, and communicating across functional departments.
• Knowledge of LMS software; ASQ Certified Quality Auditor or Certified Quality Manager certification is optional.

Nice to have

• Technical knowledge of hirify.global-type products.
• ASQ Certified Quality Auditor or Certified Quality Manager certification.

Culture & Benefits

• Hybrid and flexible work arrangements.
• Medical, dental, and vision coverage.
• 401(k) company match, bonus program, generous PTO, and paid holidays.
• Tuition reimbursement and professional development opportunities.
• Engagement events, office marketplaces, and subsidized cafeteria options.