Senior Quality Engineer (AI)

TL;DR

Senior Quality Engineer (AI): Championing consumer safety, device efficacy, and regulatory-aligned quality throughout the product lifecycle with an accent on new product development and design controls. Focus on driving technical and user-experience corrective actions, ensuring compliance with medical-device standards, and collaborating cross-functionally to deliver high-performance skincare devices.

Location: Needham, MA, United States

Salary: $83,500 - $149,500 USD

Company

hirify.global is a global product design and technology company known for disruptive innovation in home lifestyle solutions, powered by the Shark and Ninja brands.

What you will do

• Analyze consumer feedback, clinical testing outcomes, and post-market surveillance data to drive technical improvements.
• Lead quality efforts for new product development programs, including design controls, safety assessments, and human factors reviews.
• Collaborate with R&D and Clinical Affairs to define and validate critical-to-quality attributes.
• Manage root cause investigations and CAPA processes for hardware and energy-based components.
• Monitor product performance trends and deliver actionable insights to senior leadership.
• Coach junior team members to elevate technical rigor and compliance standards.

Requirements

• Bachelor’s degree in Mechanical, Biomedical, or Quality Engineering or related technical field.
• 4–7 years of experience in quality engineering with a focus on new product development.
• Experience with risk management, verification/validation, and design controls in a regulated environment.
• Proficiency with root cause analysis tools, FMEA, and statistical analysis.
• Strong knowledge of change management, CAPA processes, and manufacturing quality.
• Must be authorized to work in the United States.

Nice to have

• Working knowledge of ISO 9001, ISO 13485, IEC/UL safety standards, and ISO 14971.
• Experience with PLM platforms and eQMS tools.

Culture & Benefits

• Comprehensive health, dental, and vision insurance.
• 401(k) retirement plan with company matching.
• Generous paid time off and company holidays.
• Employee stock purchase program.
• Wellness programs and product discounts.
• Support for personal and professional growth through high-impact learning programs.