QMS Program Manager
SharkNinja
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Benefits offered by this job
Job summary
SharkNinja, Needham, MA, is seeking a QMS Program Manager, Medical Devices to own the general oversight and performance tracking of SharkNinja’s Quality Management System for medical devices, guiding NPD teams across Skincare and Wellness in developing safe and effective devices.
You will partner with Product Integrity, Product Development, Engineering, PMO, Compliance, Legal, Supply Chain, and Commercial teams to translate quality strategy into execution and lead post-market surveillance
Qualifications
- 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 in medical devices or regulated environments.
- Working knowledge of 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, 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.
Responsibilities
- Provide general oversight of QMS for medical devices, ensuring audit readiness and alignment with applicable standards.
- Track and report QMS performance with KPIs, dashboards, and management reviews, driving accountability and continuous improvement across the organization.
- Guide New Product Development (NPD) teams 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.
- Support geographic expansion of the medical devices portfolio, ensuring QMS processes and product documentation meet regional quality and regulatory expectations.
- Support Engineering Change Notices (ECNs), including impact assessment and documentation, to maintain compliance and product performance across the product lifecycle.
Skills
Education
Tools
Job description
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.
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.
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.
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.
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.
- 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.
- 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.
- Experience enabling compliant innovation in fast-paced, high-velocity consumer product environments.
- Experience supporting global market expansion and product registrations for medical devices.
- 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.
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.
Pay 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, back-up child and eldercare days, product discounts, referral bonus program, and more.
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.
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. Together, we won’t just launch products—we’ll disrupt entire markets.
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.
Life At SharkNinja
- 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 accommodations@sharkninja.com
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