Director, Quality Center of Expertise (Design Quality)

TL;DR

Director, Quality Center of Expertise (Design Quality): Leading enterprise-wide design quality strategy and governance for a global medical technology portfolio with an accent on regulatory readiness, inspection compliance, and cross-functional standardization. Focus on driving quality excellence, managing high-priority product development programs, and developing enterprise-wide quality capabilities.

Location: Must be based onsite at a designated hirify.global U.S. site (MN, CA, CO, MA, CT, TN, TX, or FL) with a minimum of 4 days per week onsite.

Salary: $184,000 – $276,000 USD

Company

hirify.global is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life for millions of patients worldwide.

What you will do

• Develop and execute enterprise-wide Design Quality strategy, standards, and governance models.
• Own enterprise Design Quality KPIs and performance management to identify trends and mitigate risks.
• Lead critical process governance for high-priority product development programs.
• Provide expert coaching and shared services to Operating Units to strengthen quality execution.
• Build enterprise capability by developing talent and creating learning pathways for quality teams.
• Influence enterprise-wide decisions regarding product safety, regulatory compliance, and brand reputation.

Requirements

• Bachelor’s degree with 10+ years of relevant experience OR Advanced degree with 8+ years of relevant experience in enterprise-scale quality leadership.
• Minimum of 7+ years of managerial experience leading large, diverse teams.
• Must be based onsite at one of the specified U.S. hirify.global campuses.
• Deep expertise in product development, Design Quality, and Quality Systems.
• Ability to lead through influence in a highly matrixed global environment.
• Must possess unrestricted U.S. work authorization (sponsorship is reserved for Principal-level and above).

Nice to have

• Knowledge of ISO 13485, EU MDR, GMP, and FDA standards.
• Experience as a contributing member of a core product development team.
• Green or Black Belt Certification.
• Experience with AI-enabled tools and prompt engineering for quality processes.

Culture & Benefits

• Comprehensive health, dental, and vision insurance.
• 401(k) plan with employer contribution and match.
• Paid time off and paid holidays.
• Tuition assistance and reimbursement programs.
• Employee Stock Purchase Plan and well-being programs.
• Commitment to an inclusive, ethical, and continuous-improvement culture.