Director - Medical Device QMS

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 3,600+ associates, the company's products are sold at key retailers, online and offline, and through distributors around the world.
The Director of Medical Device QMS for New Product Design will lead the quality management initiatives for the development of new medical devices and ensure compliance of product in market. This strategic role is crucial for ensuring that all new products are designed and developed in compliance with regulatory standards, promoting a culture of quality throughout the product lifecycle, and ensuring we are executing to our QMS policy and procedures.
Key Responsibilities:

• QMS Strategy Development: Develop and implement the Quality Management System (QMS) for our medical device portfolio, ensuring alignment with regulatory requirements (e.g., FDA, ISO 13485).

• Cross-Functional Leadership: Collaborate with R&D, engineering, marketing, and production teams to integrate quality principles into the new product design process and legacy product maintenance to ensure quality is embedded from the outset.

• Regulatory Compliance Oversight: Ensure that all new medical devices meet applicable regulatory standards throughout the design and development phases, including managing submissions and audits.

• Risk Management: Lead risk management activities during the product design phase, conducting thorough assessments and ensuring appropriate mitigation strategies are in place.

• Training and Development: Establish training programs to promote quality awareness and best practices related to new product development among cross-functional teams.

• Quality Metrics and Reporting: Define and track quality metrics related to new product design, preparing regular reports for senior management that highlight compliance status, risks, and opportunities for improvement.

• Continuous Improvement: Drive initiatives to enhance the QMS processes related to new product design, leveraging feedback and data analysis to implement best practices.

• Stakeholder Communication: Act as the primary point of contact for quality-related inquiries concerning new product design, ensuring clear communication with internal and external stakeholders.

Qualifications:

• Bachelor's degree in Engineering, Quality Assurance, Life Sciences, or a related field; advanced degree preferred.

• Minimum of 10 years of experience in quality management within the medical device or regulated consumer goods industries, with a focus on new product development.

• Deep understanding of regulatory requirements (FDA, ISO 13485) and quality management systems.

• Proven track record of successfully leading quality initiatives in a product development context.

• Strong leadership and interpersonal skills, with the ability to influence and engage cross-functional teams effectively.

• Excellent analytical and problem-solving skills, with a commitment to data-driven decision-making.

• Strong communication skills, capable of conveying complex information to diverse audiences.

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 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.
This posting will close within 90 days from the original posting date.
Pay Range
$190,530-$232,870 USD
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. 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.
Learn more about us:
Life At SharkNinja
Outrageously Extraordinary
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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 [email protected]