QMS PROGRAM MANAGER

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 trusted brands Shark and Ninja, the company drives innovation across multiple product categories, achieving significant growth and market share gains. Headquartered in Needham, Massachusetts, SharkNinja employs over 4,100 associates and sells products through key retailers and distributors worldwide.

At SharkNinja, we’re building an AI-native culture where bold experimentation, adoption of new tools, and continuous innovation are expected. If you thrive on creating what hasn’t been invented yet, this is the place for you.

About the role

As the QMS Program Manager for Medical Devices, you will oversee and track the performance of SharkNinja’s Quality Management System (QMS) for medical devices. You will guide New Product Development (NPD) teams in Skincare and Wellness to ensure safe and effective devices are designed from concept through post-market. This role ensures quality and safety are embedded into the product lifecycle while supporting SharkNinja’s fast-paced, consumer-driven development model.

You will collaborate with Product Integrity, Product Development, Engineering, PMO, Compliance, Legal, Supply Chain, and Commercial teams to execute quality strategy, support geographic expansion of the medical devices portfolio, and lead post-market surveillance activities.

Responsibilities

• Provide oversight of SharkNinja’s QMS for medical devices, ensuring it remains effective, audit-ready, and aligned with standards such as ISO 13485 and FDA 21 CFR Part 820/QMSR.
• Track and report QMS performance using KPIs, dashboards, and management reviews to drive accountability and continuous improvement.
• Guide NPD teams in embedding design controls, risk management (ISO 14971), and verification/validation into the development process for safe and effective devices.
• Translate quality and safety requirements into clear, actionable guidance for Product Development and Engineering teams.
• Partner with cross-functional teams to advocate for Medical Device Compliance and Consumer needs in design reviews and change-management forums.
• Influence senior stakeholders to align on quality priorities, trade-offs, and risk-mitigation strategies.
• Support geographic expansion by ensuring QMS processes and documentation meet regional regulatory expectations in new and emerging markets.
• Lead post-market surveillance and support Engineering Change Notices (ECNs), including impact assessments and compliance documentation.

Requirements

• 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 in 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.
• Proven ability to lead complex, cross-functional programs and collaborate effectively across R&D, Engineering, Regulatory, Quality, and Commercial teams in matrixed organizations.
• Strong communication skills to translate quality and regulatory complexity into practical product and engineering guidance.

Preferred Qualifications

• Experience enabling compliant innovation in fast-paced, high-velocity consumer product environments.
• Experience supporting global market expansion and product registrations for medical devices.

Skills

• Strategic thinker with strong execution discipline.
• Data-driven problem solver with a pragmatic, risk-based mindset.
• Comfortable operating in ambiguity and fast-paced environments.
• Collaborative, credible leader with strong business judgment and a consumer-first mindset.

Pay

Pay Range: $107,100—$150,000 USD

Benefits

• Medical, dental, and vision insurance.
• Flexible spending accounts and health savings accounts (HSA) with company contribution.
• 401(k) retirement plan with matching.
• Employee stock purchase program.
• Life insurance, AD&D, short-term and long-term disability insurance.
• Generous paid time off, company holidays, and parental leave.
• Identity theft protection and pet insurance.
• Pre-paid legal insurance.
• Back-up child and eldercare days.
• Product discounts and referral bonus program.
• Wellness programs.
• High-impact Learning Programs featuring bold voices redefining innovation.

Our Culture

At SharkNinja, we push boundaries daily with an Outrageously Extraordinary mindset, tackling the impossible and delivering results others only dream of. We empower personal and professional growth, fostering a community where diversity, equity, and inclusion drive innovation. Every associate is encouraged to bring their authentic self to work, make an impact, and accelerate their career.