Quality System Compliance Manager (Medical Device)

TL;DR

Quality System Compliance Manager (Medical Devices): Leading the design and implementation of the Quality Management System (QMS) for medical devices with an accent on regulatory compliance and integration into high-velocity product development. Focus on operationalizing QMS across engineering and product teams while ensuring adherence to 21 CFR Part 820, ISO 13485, and EU MDR.

Location: Must be based in the United States

Salary: $131,900 - $161,200 USD

Company

hirify.global is a global product design and technology company known for disruptive innovation in lifestyle solutions through its brands Shark and Ninja.

What you will do

• Own and evolve the global Medical Devices QMS, ensuring compliance with 21 CFR Part 820 / QMSR, ISO 13485, MDSAP, and EU MDR.
• Integrate quality system requirements directly into NPD workflows and digital tools such as PLM, Veeva, Greenlight Guru, and JIRA.
• Establish QMS governance, decision rights, and escalation mechanisms across different programs and geographies.
• Lead internal and external audits, regulatory inspections, and management reviews as the primary quality systems authority.
• Oversee core QMS processes, including document control, CAPAs, NCRs, training, and supplier quality management.
• Partner with Engineering, PMO, Regulatory, and Legal teams to embed quality into day-to-day execution.

Requirements

• Must be based in the United States.
• Bachelor’s or Master’s degree in Engineering, Life Sciences, Quality, or a related technical discipline.
• 7–10+ years of experience in medical device quality systems, ideally within consumer electronics or high-velocity environments.
• Proven experience implementing QMS compliant with 21 CFR Part 820, ISO 13485, and EU MDR within an MDSAP framework.
• Deep understanding of design controls and risk management for electromechanical devices (ISO 14971, DFMEA).
• Strong cross-functional influence and stakeholder management skills in matrixed organizations.

Culture & Benefits

• Comprehensive health benefits: medical, dental, vision, and HSA with company contributions.
• Financial security through a 401(k) retirement plan with matching and an employee stock purchase program.
• Generous paid time off, company holidays, and parental leave.
• Practical perks including product discounts, identity theft protection, and pre-paid legal insurance.
• Supportive environment focused on diversity, equity, and inclusion.