Director, Device Quality (Medtech)

TL;DR

Director, Device Quality (Medtech): Leading and evolving the medical device Quality Management System (QMS) to ensure compliance with global regulatory requirements and industry standards. Focus on QMS development, regulatory compliance (ISO 13485, FDA QSR, EU MDR), and fostering a proactive quality culture across the organization.

Location: On-site in Minnetonka, Minnesota, USA

Company

hirify.global is a leading health and wellness platform, a public company traded on the NYSE, focused on redefining healthcare through affordable, accessible, and personal care.

What you will do

• Own the development, implementation, and continuous improvement of the QMS in alignment with ISO 13485, FDA QSR, and EU MDR.
• Serve as the Management Representative for the QMS and as Person Responsible for Regulatory Compliance (PRRC) under EU MDR.
• Oversee technical documentation, product labeling, post-market surveillance, vigilance reporting, and corrective actions.
• Lead core quality processes including CAPA, nonconformance, complaint handling, change control, risk management, and supplier quality management.
• Partner with cross-functional teams to embed quality throughout the product lifecycle and provide regulatory training and guidance.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related discipline.
• 10+ years of experience in medical device quality assurance, including leadership of regulated QMS environments.
• Deep expertise in ISO 13485, FDA Quality System Regulation, EU MDR, and risk management principles.
• Experience leading FDA inspections, ISO audits, and Notified Body audits.
• Strong problem-solving skills with demonstrated success driving CAPA effectiveness.
• Executive-level communication skills and ability to influence cross-functional stakeholders.

Nice to have

• Master’s degree preferred.
• Sterilization experience preferred.
• Experience working within an electronic Quality Management System (eQMS).

Culture & Benefits

• Competitive salary & equity compensation.
• Unlimited PTO, company holidays, and quarterly mental health days.
• Comprehensive health benefits including medical, dental & vision, and parental leave.
• 401k benefits with employer matching contribution and Employee Stock Purchase Program (ESPP).
• Commitment to a diverse workforce, ethics, wellness, and a strong sense of belonging.
• Team retreats and a talent-first flexible/remote work approach.