Quality System Compliance Manager - Medical Device

About the role

The Quality System Compliance Manager, Medical Devices, leads the design, implementation, and continuous improvement of SharkNinja’s Quality Management System (QMS) for medical devices. This role ensures regulatory compliance while shaping a QMS that integrates seamlessly into SharkNinja’s consumer electronics product development processes.

Responsibilities

• Own and evolve the global Medical Devices QMS, ensuring compliance with 21 CFR Part 820 / QMSR, ISO 13485, MDSAP, and EU MDR.
• Establish QMS governance, decision rights, and escalation mechanisms for consistent execution across products, programs, and geographies.
• Maintain a risk-based, audit-ready QMS supporting development, commercialization, and lifecycle activities in North America, the EU, and MDSAP-participating markets.
• Design a QMS aligned with SharkNinja’s consumer electronics NPD model, emphasizing embedded controls, simplified documentation, digital evidence, and distributed ownership.
• Embed QMS into NPD processes and digital tools, integrating quality system requirements into existing workflows and platforms to ensure design controls, risk management, change management, and documentation are executed within standard development workflows with minimal manual overhead and clear, audit-ready digital evidence.
• Lead and support internal audits, external audits, regulatory inspections, and management reviews, serving as the primary quality systems authority.
• Oversee core QMS processes, including document control, NCRs, CAPAs, training, supplier quality management, post-market surveillance, and change management, fostering a quality culture where QMS activities are embedded into day-to-day execution and enable speed, clarity, accountability, and informed risk-taking.

Qualifications & Experience

• 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, preferably within consumer electronics, electromechanical devices, or high-velocity product development environments.
• Demonstrated experience designing, implementing, and operating QMS compliant with 21 CFR Part 820 / FDA QMSR, ISO 13485, EU MDR, within an MDSAP-aligned audit framework.
• Strong hands-on experience with core QMS processes, including document control, CAPA, NCRs, audits, training, supplier quality management, and post-market surveillance.
• Deep understanding of design controls and risk management for electromechanical medical devices, including ISO 14971, hazard analysis, DFMEA, and lifecycle risk management.
• Pragmatic, systems-thinking mindset with a proven ability to operationalize QMS compliance in fast-paced, innovation-driven environments.

Benefits

The Company offers a comprehensive benefits package, including:

• Medical insurance
• Dental insurance
• Vision insurance
• Flexible spending accounts
• Health savings accounts (HSA) with company contribution
• 401(k) retirement plan with matching
• Employee stock purchase program
• Life insurance
• AD&D
• Short-term disability insurance
• Long-term disability insurance
• Generous paid time off
• Company holidays
• Parental leave
• Identity theft protection
• Pet insurance
• Pre-paid legal insurance
• Back-up child and eldercare days
• Product discounts
• Referral bonus program

Culture

At SharkNinja, we embrace diversity, equity, and inclusion, valuing each unique voice and blending diverse skills to drive innovation. We support all associates in bringing their authentic selves to work, making an impact, and accelerating their careers.