QMS Program Manager (Medical Devices)

TL;DR

QMS Program Manager (Medical Devices): Overseeing and tracking the performance of the Quality Management System for medical devices with an accent on NPD guidance, safety, and regulatory compliance. Focus on embedding design controls and risk management into the product lifecycle for skincare and wellness devices.

Location: Needham, MA, United States

Salary: $107,100 - $150,000 USD

Company

hirify.global is a global product design and technology company known for its disruptive innovation in lifestyle solutions through the Shark and Ninja brands.

What you will do

• Provide general oversight of the Quality Management System (QMS) to ensure it remains effective and audit-ready per ISO 13485 and FDA standards.
• Guide New Product Development (NPD) teams in skincare and wellness to embed design controls, risk management, and validation processes.
• Track and report QMS performance using KPIs and dashboards to drive continuous organizational improvement.
• Collaborate with Product Integrity, Engineering, and Legal teams to translate quality strategies into execution.
• Support geographic expansion of the medical devices portfolio by ensuring documentation meets regional regulatory expectations.
• Manage post-market surveillance and Engineering Change Notices (ECNs) to maintain compliance across the product lifecycle.

Requirements

• Bachelor’s or Master’s degree in Engineering, Life Sciences, Quality, or a related technical field.
• 7–10+ years of experience in quality, QMS, or program management, specifically within medical or electromechanical devices.
• Working knowledge of ISO 13485, ISO 14971, FDA 21 CFR Part 820 / QMSR, CAPA, and post-market surveillance.
• Proven ability to lead complex cross-functional programs in matrixed organizations.
• Strong communication skills to translate regulatory complexity into practical engineering guidance.

Nice to have

• Experience enabling compliant innovation within fast-paced consumer product environments.
• Experience supporting global market expansion and product registrations for medical devices.

Culture & Benefits

• Comprehensive health, dental, and vision insurance.
• 401(k) retirement plan with company matching and an employee stock purchase program.
• Health Savings Account (HSA) with company contribution.
• Generous paid time off, company holidays, and parental leave.
• Additional perks including pet insurance, pre-paid legal insurance, and product discounts.