QMS Program Manager

SharkNinja · 15100 - Quality Manufacturing

Pay: $107,100–$150,000/yr
Where: Needham, MA, United States
Posted: Aug 6

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.

What you'd do

Provide general oversight of SharkNinja’s Quality Management System for medical devices, ensuring it remains effective, audit-ready, and aligned with applicable standards (e.g., ISO 13485, FDA 21 CFR Part 820 / QMSR).
Track and report QMS performance through clear KPIs, dashboards, and management reviews, driving accountability and continuous improvement across the organization.
Guide New Product Development (NPD) teams across Skincare and Medical Devices in developing safe and effective devices, embedding design controls, risk management (ISO 14971), and verification and validation into the development process.
Translate quality and safety requirements into clear, digestible, execution-ready guidance for Product Development and Engineering teams.
Partner with cross-functional teams to build safe and effective medical devices, serving as a voice of Medical Device Compliance and Consumer in design reviews, product development, and change-management forums.
Influence senior stakeholders to align on quality priorities, trade-offs, and risk-mitigation strategies.
Support the geographic expansion of the medical devices portfolio, ensuring QMS processes and product documentation meet regional quality and regulatory expectations in new and emerging markets.
Support Engineering Change Notices (ECNs), including impact assessment and documentation, to maintain compliance and product performance across the product lifecycle.
Strategic thinker with strong execution discipline.
Data-driven problem solver with a pragmatic, risk-based mindset.

What they want

Bachelor’s or master’s degree in engineering, Life Sciences, Quality, or a related technical discipline.
7–10+ years of experience in quality, QMS, or program management, preferably within medical devices, electromechanical devices, or regulated consumer product environments.
Working knowledge of medical device quality requirements, including ISO 13485, ISO 14971, FDA 21 CFR Part 820 / QMSR, design controls, CAPA, and post-market surveillance.
Demonstrated ability to lead complex, cross-functional programs and partner effectively across R&D, Engineering, Regulatory, Quality, and Commercial teams in matrixed organizations.
Strong communication skills with the ability to translate quality and regulatory complexity into practical product and engineering guidance.