QMS Program Manager, Medical Devices & NPD

Ninjakitchen; 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 match

Employee stock purchase

Job summary

SharkNinja in Needham, MA is seeking a QMS Program Manager, Medical Devices, to own oversight of the QMS and guide NPD teams across skincare and medical devices. This role ensures quality and safety from concept through post-market while enabling fast-paced product development.

You will collaborate with Product Integrity, Product Development, Engineering, PMO, Compliance, Legal, Supply Chain, and Commercial teams to translate quality strategy into execution and support global market expansion.

Qualifications

• Bachelor’s or master's degree in engineering, Life Sciences, Quality, or related technical discipline.
• 7–10+ years of experience in quality, QMS, or program management in regulated environments.
• Working knowledge of medical device quality requirements, including ISO 13485, ISO 14971, FDA 21 CFR Part 820 / QMSR.
• Ability to lead cross-functional programs across R&D, Engineering, Regulatory, Quality, and Commercial teams.
• Strong communication skills translating regulatory complexity into practical guidance.

Responsibilities

• Oversee SharkNinja’s QMS for medical devices, ensuring audit readiness and compliance.
• Lead NPD guidance embedding design controls, risk management, and verification/validation.
• Collaborate with cross-functional teams and influence senior stakeholders on priorities.
• Support geographic expansion ensuring regional quality and regulatory compliance.
• Manage post-market surveillance and change management activities.

Skills

Quality management

Cross-functional collaboration

Regulatory knowledge

Project management

Communication skills

Education

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

Tools

ISO 13485

FDA 21 CFR Part 820 / QMSR

Job description

SharkNinja in Needham, MA is seeking a QMS Program Manager, Medical Devices, to own oversight of the QMS and guide NPD teams across skincare and medical devices. This role ensures quality and safety from concept through post-market while enabling fast-paced product development.

You will collaborate with Product Integrity, Product Development, Engineering, PMO, Compliance, Legal, Supply Chain, and Commercial teams to translate quality strategy into execution and support global market expansion.