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.