Senior Quality Director (Medical Devices)

TL;DR

Senior Quality Director (Medical Devices): Leading corporate quality and compliance across global manufacturing sites, with an accent on medical device regulations, audits, CAPA management, validation, and quality system improvement. Focus on managing complex regulatory requirements, driving root-cause investigations, strengthening supplier and customer quality processes, and ensuring reliable compliance across cross-functional operations.

Location: Hybrid work schedule with onsite work required in the Waltham, Massachusetts office, United States.

Salary: $220,000–$300,000 per year.

Company

hirify.global develops and manufactures scientific, biopharmaceutical, and in vitro diagnostic instruments used in drug development and patient care worldwide.

What you will do

• Lead corporate quality and compliance activities across global manufacturing sites and subsidiaries.
• Manage internal and external audits involving regulatory bodies, partners, customers, and other auditing organizations.
• Oversee CAPAs, failure investigations, NIRs, shipping holds, NCMRs, MRB approvals, and supplier quality actions.
• Lead quality training, validation activities, quality metrics, KPIs, and management review reporting.
• Develop quality plans for product development and new initiatives while driving process improvements.
• Partner with R&D, Manufacturing, Engineering, Supplier Quality Engineering, Purchasing, Incoming Inspection, 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 experience managing quality programs in the medical diagnostic or medical device industry.
• 12+ years of quality team management experience.
• Working knowledge of GMP and experience applying root-cause analysis and structured problem-solving methods.
• Experience leading internal and external audits, driving process improvements, and communicating across functional departments.
• Knowledge of LMS software and strong organizational, communication, and presentation skills.

Nice to have

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

Culture & Benefits

• Hybrid and flexible work arrangements with onsite office collaboration.
• Medical, dental, and vision coverage.
• Competitive 401(k) company match, bonus program, generous PTO, and paid holidays.
• Tuition reimbursement and professional development opportunities.
• Employee engagement events, office food benefits, and a collaborative culture centered on customer focus, ownership, integrity, and innovation.