Smarter Alloys | Cambridge, ON (On Site) Full Time, 1-Year Fixed-Term

The Role
This is a role where quality and regulatory work directly enables products to reach market. You will own our ISO 13485 system, lead audits, and guide regulatory strategy for new and existing medical device products, but the real impact is in clearing the path from development to commercialization.

We need someone who can balance maintaining a certified QMS with actively supporting new product introductions, navigating regulatory submissions, and working shoulder to shoulder with engineering and production as we scale.

If you want a role where compliance isn't a back office function but a core part of how products get to market, this is it.

About Smarter Alloys
Smarter Alloys develops and manufactures advanced shape memory alloy materials and devices for medical, dental, automotive, consumer, and energy applications. We are certified to ISO 13485 MDSAP and registered with the FDA and Health Canada. Our product portfolio is expanding, our customer base is growing, and we need a quality and regulatory leader who can scale with us.

What You Will Do

Lead internal and external audits, including ISO surveillance audits, customer audits, and regulatory inspections

Own and maintain the ISO 13485 Quality Management System, ensuring ongoing compliance and continuous improvement

Support regulatory activities for medical device products, including FDA establishment registration and listing

Guide regulatory requirements for new product development from concept through commercialization

Oversee CAPA, nonconformance management, and continuous improvement initiatives

Maintain and improve quality documentation including SOPs, work instructions, risk management files, and technical files

Support supplier qualification, monitoring,



and quality agreements

Train and support internal teams on quality system requirements and regulatory expectations

Collaborate cross functionally with engineering, production, procurement, and business development

Serve as the primary point of contact for quality and regulatory matters, internally and externally

Who You Are

Bachelor's degree in Engineering, Science, or a related technical discipline

4+ years of experience in quality and regulatory roles within the medical device industry

Strong working knowledge of ISO 13485 and FDA Quality System Regulation

Demonstrated experience leading audits and managing regulatory inspections

Proven ability to manage and improve a QMS in a hands on environment

Strong documentation, organizational, and communication skills

Able to work independently and exercise sound judgment in a regulated setting

Strongest Candidates Will Also Have

Experience supporting dental or Class I/II medical devices

Familiarity with ISO 14971 (risk management)

Experience in a startup or growing organization

Exposure to advanced materials or precision manufacturing environments

Experience supporting regulatory submissions or international registrations

What We Offer

Competitive compensation package with full benefits and paid vacation

The chance to own and shape the quality function at a company with real momentum

Direct impact on products reaching market. Your work clears the path.

A rapid moving, collaborative team that values results and initiative

On site role based out of our Cambridge, ON facility

Smarter Alloys is committed to building a diverse and inclusive team. We welcome applications from women, visible minorities, Indigenous peoples, people identifying as LGBTQ2SI+, veterans, and people with disabilities.

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📌 Quality and Regulatory Manager (Ontario)
🏢 Smarter Alloys
📍 Ontario