Join Smarter Alloys in Cambridge, ON as a Quality and Regulatory Manager where your expertise drives products from development to market. Shape strategy, lead audits, and ensure compliance in a collaborative environment. In this full time, permanent role, you will own the ISO 13485 Quality Management System while actively supporting current product introductions.

Your experience will help navigate the regulatory landscape for medical devices, ensuring effective submissions to the FDA and Health Canada. Collaborate with engineering and production teams to maintain quality and compliance throughout the product lifecycle. Key Responsibilities:
Lead internal and external audits for compliance
Own and maintain the ISO 13485 Quality Management System




Support regulatory activities for medical devices
Guide requirements from concept through commercialization
Oversee CAPA and continuous improvement initiatives

Requirements:
Bachelor's in Engineering, Science, or related field
4+ years in quality and regulatory roles
Strong knowledge of ISO 13485 and FDA regulations
Experience managing QMS in a hands-on workplace
Proven track record in leading audits

Your leadership will ensure that quality and regulatory compliance are integral to Smarter Alloys' success.

📌 Quality Manager For Medical Devices Waterloo
🏢 Smarter Alloys
📍 Waterloo