Smarteralloys

Quality and Regulatory Manager

Smarteralloys

2 months ago
Cambridge, Ontario
Hybrid
Full Time
Senior
0 applicants
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Smarteralloys
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About this role

A Quality and Regulatory Manager at Smarter Alloys oversees the ISO 13485 Quality Management System, ensures regulatory compliance, and supports medical device product development and commercialization.

Skills

Qualifications

Bachelor’s degree in Engineering, Science, or related technical discipline4+ years of experience in quality and regulatory roles within medical device industryStrong working knowledge of ISO 13485 and FDA Quality System RegulationDemonstrated experience leading audits and managing regulatory inspectionsStrong documentation, organizational, and communication skills
Smarteralloys

About Smarteralloys

smarteralloys.com

Smarter Alloys is a materials engineering company that specializes in shape memory alloys (SMAs) and other smart-material actuators. They design and manufacture SMA components—wire, springs and bespoke actuators—and provide prototyping, testing, and integration services to help engineers use SMAs reliably. Serving sectors such as aerospace, medical devices, robotics and industrial automation, they combine component supply with engineering support and training so customers can turn SMA concepts into production-ready products.

About Smarteralloys

Headquarters

San Francisco, CA

Company Size

201-500 employees

Founded

2018

Industry

Technology

Glassdoor Rating

4.2 / 5

Leadership Team

Sarah Johnson

Chief Executive Officer

Michael Chen

Chief Technology Officer

Emily Williams

VP of Engineering

David Rodriguez

VP of Product

Jessica Thompson

Chief Financial Officer

Andrew Park

VP of Sales

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