Quality System Compliance Manager

Responsibilities

• Own and evolve the global Medical Devices Quality Management System (QMS) ensuring compliance with 21 CFR Part 820, ISO 13485, MDSAP, and EU MDR
• Establish QMS governance, decision rights, and escalation mechanisms
• Maintain a risk-based, audit-ready QMS supporting development and commercialization
• Design a QMS aligned to consumer electronics NPD models with embedded controls and digital evidence
• Integrate quality requirements into digital tools like PLM, Veeva, Greenlight Guru, and JIRA
• Lead internal and external audits, regulatory inspections, and management reviews
• Oversee core QMS processes including document control, CAPA, NCRs, and supplier quality management

Requirements

• 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
• Experience with 21 CFR Part 820, ISO 13485, EU MDR, and MDSAP
• Expertise in design controls and risk management (ISO 14971, DFMEA)
• Strong experience with CAPA, NCRs, and post-market surveillance
• Proven ability to work in high-velocity, innovation-driven environments

Preferred Qualifications

• Experience within consumer electronics or electromechanical device development
• Proficiency with digital QMS tools and PLM systems

About the Company

SharkNinja is a global product design and technology company with a diversified portfolio of lifestyle solutions. Powered by the Shark and Ninja brands, the company focuses on bringing disruptive innovation to market across multiple product categories.