Quality System Compliance Manager - Medical Device

About the role

SharkNinja is a global product design and technology company, with a diversified portfolio of 5-star rated lifestyle solutions that positively impact people's lives in homes around the world. Powered by two trusted, global brands, Shark and Ninja , the company has a proven track record of bringing disruptive innovation to market and developing one consumer product after another has allowed SharkNinja to enter multiple product categories, driving significant growth and market share gains. Headquartered in Needham, Massachusetts with more than 4,100 associates, the company's products are sold at key retailers, online and offline, and through distributors around the world. AI at SharkNinja At SharkNinja, we're building an AI-native culture. We're not waiting for the future; we're creating it. Our people are expected to experiment boldly, adopt new tools, and continuously raise what's possible to create meaningful impact for our consumers. If you believe the best way to do your job hasn't been invented yet, you'll fit right in. Quality System Compliance Manager, Medical Devices As the Quality System Compliance Manager, Medical Devices, you will lead the design, implementation, and continuous improvement of SharkNinja's Quality Management System (QMS) for medical devices. This role is accountable for ensuring regulatory compliance while deliberately shaping a QMS that works within a high-velocity, consumer electronics product development environment. You will establish a QMS that is integrated, digital-first, and ownership-driven-aligned to SharkNinja's specification developer model and embedded directly into existing new product development (NPD) processes rather than operating as a parallel or centralized function. The role partners closely with Engineering, PMO, Quality, Regulatory, Legal, and Product teams to ensure quality is operationalized across the organization and supports rapid innovation and scale.

Responsibilities

• Own and evolve the global Medical Devices Quality Management System (QMS), ensuring sustained compliance with 21 CFR Part 820 / QMSR, ISO 13485, MDSAP, and EU MDR, while enabling rapid, concurrent product development across multiple programs.
• Establish QMS governance, decision rights, and escalation mechanisms to ensure consistent execution across products, programs, and geographies.
• Maintain a risk-based, audit-ready QMS supporting development, commercialization, and lifecycle activities across North America, the EU, and MDSAP-participating markets.
• Design a QMS aligned to SharkNinja's consumer electronics NPD model, emphasizing embedded controls, simplified documentation, digital evidence, and distributed ownership rather than centralized quality gatekeeping.
• Lead and support internal audits, external audits, regulatory inspections, and management reviews, serving as the primary quality systems authority.
• 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.
• Strong cross-functional influence, communication, and stakeholder management skills in complex, matrixed organizations.
• Pragmatic, systems-thinking mindset with a proven ability to operationalize QMS compliance in fast-paced, innovation-driven environments.
• Salary and Other Compensation: The annual salary range for this position is displayed below. Factors which may affect starting pay within this range may include geography/market, skills, education, experience and other qualifications of the successful candidate.
• The Company offers the f

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