Quality System Compliance Manager - Medical Device

SharkNinja is seeking a Quality System Compliance Manager, Medical Devices to lead the design, implementation, and continuous improvement of the company's Quality Management System (QMS) for medical devices. The role requires a strong understanding of regulatory compliance and a proven ability to operationalize QMS compliance in fast-paced, innovation-driven environments.

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, 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.

Benefits

• 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