QMS Program Manager

About Us

SharkNinjais a global product design and technology company with a diversified portfolio of 5-star rated lifestyle solutions that positivelyimpactpeoples lives in homes around the world. Powered by two trusted global brands Shark and Ninja the company has a proventrack recordof bringing disruptive innovation to market and developing one consumer product after another has allowedSharkNinjato enter multiple product categories driving significant growth and market share gains. Headquartered in Needham Massachusetts with more than4100associates the companys products are sold at key retailers online and offline and through distributors around the world.

AI at SharkNinja

At SharkNinja were building an AI-native culture. Were not waiting for the future; were creating it. Our people are expected to experiment boldly adopt new tools and continuously raise whats possible to create meaningful impact for our consumers. If you believe the best way to do your job hasnt been invented yet youll fit right in.

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 SharkNinjas Quality Management System (QMS) as it applies to medicaldevices andguide New Product Development (NPD) teams across SkincareandWellnessin developing safe and effective devices. This role ensures quality and safety are designed into products from concept through post-marketwhile enabling SharkNinjas fast-paced consumer-driven product development model.

Partnering closely withProduct Integrity Product Development EngineeringPMOComplianceLegalSupply Chain and Commercial teams you will translate quality strategy into execution support the geographic expansion of the medicaldevicesportfolio and lead post-market surveillance activitiesensuring quality is embedded into the product lifecycle not inspected in after the fact.

Key Responsibilities

QMS Oversight & Performance Tracking

• Provide general oversight of SharkNinjas 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 voiceof Medical Device Compliance and Consumerin 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 medicaldevicesportfolio 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

• Bachelors ormasters degree in engineering Life Sciences Quality or a related technical discipline.

• 710 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.