QMS Program Manager

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 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.

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.