QMS Program Lead, Medical Devices

SharkNinja; Needham (MA); On-site; USD 107,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with matching

Employee stock purchase program

Paid time off

Parental leave

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

Quality systems

Regulatory knowledge

Cross-functional leadership

Documentation & CAPA

Education

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

Tools

ISO 13485 familiarity

Job description

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