QMS Program Manager

Socket.dev; Needham (MA); On-site; USD 107,000 - 150,000; Full time

Job summary

SharkNinja is seeking a QMS Program Manager for Medical Devices in Needham, MA. You will oversee the Quality Management System for medical devices, guiding NPD teams and coordinating with Product Integrity, Engineering, Regulatory, and Compliance to ensure safe, compliant products from concept to post-market.

Ideal candidates have 7–10+ years in quality/QMS for regulated products, with strong knowledge of ISO 13485, ISO 14971, and FDA 21 CFR Part 820.

Qualifications

• Bachelor’s or master’s degree in engineering, Life Sciences, Quality or related field.
• 7–10+ years of experience in quality, QMS, or program management, ideally in medical devices or regulated products.
• Knowledge of ISO 13485, ISO 14971, FDA 21 CFR Part 820 / QMSR, design controls, CAPA, and post-market surveillance.
• Proven ability to lead complex programs and partner with R&D, Engineering, Regulatory, Quality, and Commercial teams.
• Strong communication skills and ability to translate complexity into practical guidance.

Responsibilities

• Provide QMS oversight for medical devices, ensuring audit readiness and compliance with standards.
• Track QMS performance via KPIs, dashboards, and management reviews; drive continuous improvement.
• Guide NPD teams in designing safe and effective devices with design controls and risk management.
• Collaborate across functions to align quality priorities and risk mitigation strategies.
• Support geographic expansion with compliant documentation and regional quality expectations.
• Assist in post-market surveillance and handling ECNs to maintain product performance.

Skills

Quality leadership

Regulatory knowledge

Cross-functional collaboration

Communication

Education

Bachelor’s or Master’s degree in engineering, Life Sciences, Quality

Job description

About Us

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.

QMS Program Manager, Medical Devices

Needham, MA, United States

As the QMS Program Manager, Medical Devices, you will own the general oversight and performance tracking of SharkNinja’s Quality Management System (QMS) as it applies to medical devices and guide New Product Development (NPD) teams across Skincare and Wellness in developing safe and effective devices. This role ensures quality and safety are designed into products from concept through post-market—while enabling SharkNinja’s fast-paced, consumer-driven product development model.

Partnering closely with Product Integrity, Product Development, Engineering, PMO, Compliance, Legal Supply Chain, and Commercial teams, you will translate quality strategy into execution, support the geographic expansion of the medical devices’ portfolio, and lead post-market surveillance activities—ensuring quality is embedded into the product lifecycle, not inspected in after the fact.

Key Responsibilities

QMS Oversight & Performance Tracking

• Provide general overview 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.

NPD Guidance – Safe & Effective Devices

• 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.

Cross-Functional Collaboration

• 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.

Geographic Expansion

• 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.

Post-Market Surveillance & Change Management

• Support Engineering Change Notices (ECNs), including impact assessment and documentation, to maintain compliance and product performance across the product lifecycle.

Qualifications & Experience

Required

• 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.

Preferred

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

Key Competencies

• 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.

Salary and Other Compensation

Salary range: $107,100 — $150,000 USD.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: 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, backup child and eldercare days, product discounts, referral bonus program, and more.

Our Culture

At SharkNinja, we don’t just raise the bar—we push past it every single day. Our Outrageously Extraordinary mindset drives us to tackle the impossible, push boundaries, and deliver results that others only dream of. If you thrive on breaking out of your swim lane, you’ll be right at home.

What We Offer

We offer competitive health insurance, retirement plans, paid time off, employee stock purchase options, wellness programs, SharkNinja product discounts, and more. We empower your personal and professional growth with high impact Learning Programs featuring bold voices redefining what’s possible. When you join, you’re not just part of a company—you’re part of an outrageously extraordinary community.

At SharkNinja, Diversity, Equity, and Inclusion are vital to our global success. Valuing each unique voice and blending all of our diverse skills strengthens SharkNinja’s innovation every day. We support ALL associates in bringing their authentic selves to work, making an impact, and having the opportunity for career acceleration. With help from our leadership, associates, and our community, we aim to have equity be a key component of the SharkNinja DNA.

Learn more about us: Life At SharkNinja Outrageously Extraordinary

SharkNinja Candidate Privacy Notice

• For candidates based in all regions, please refer to this Candidate Privacy Notice.
• For candidates based in China, please refer to this Candidate Privacy Notice.
• For candidates based in Vietnam, please refer to this Candidate Privacy Notice.

We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, disability, or any other class protected by legislation, and local law. SharkNinja will consider reasonable accommodations consistent with legislation, and local law. If you require a reasonable accommodation to participate in the job application or interview process, please contact SharkNinja People & Culture at [e-mail]