Quality and Regulatory Manager

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    "description": "<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 24pt\">Quality and Regulatory Manager</span></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif\"><span style=\"font-weight: bold\">Smarter Alloys | Cambridge, ON (On Site)</span><span> </span><span style=\"font-weight: bold\">Full time, permanent</span></span></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 18pt\">The Role</span></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif\">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.</span></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif\">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.</span></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif\">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.</span></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 18pt\">About Smarter Alloys</span></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif\">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.</span></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 18pt\">What You Will Do</span></p>\n<ul>\n<li><span style=\"font-family: arial, helvetica, sans-serif\">Lead internal and external audits, including ISO surveillance audits, customer audits, and regulatory inspections</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif\">Own and maintain the ISO 13485 Quality Management System, ensuring ongoing compliance and continuous improvement</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif\">Support regulatory activities for medical device products, including FDA establishment registration and listing</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif\">Guide regulatory requirements for new product development from concept through commercialization</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif\">Oversee CAPA, nonconformance management, and continuous improvement initiatives</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif\">Maintain and improve quality documentation including SOPs, work instructions, risk management files, and technical files</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif\">Support supplier qualification, monitoring, and quality agreements</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif\">Train and support internal teams on quality system requirements and regulatory expectations</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif\">Collaborate cross functionally with engineering, production, procurement, and business development</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif\">Serve as the primary point of contact for quality and regulatory matters, internally and externally</span></li>\n</ul>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 18pt\">Who You Are</span></p>\n<ul>\n<li><span style=\"font-family: arial, helvetica, sans-serif\">Bachelor's degree in Engineering, Science, or a related technical discipline</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif\">4+ years of experience in quality and regulatory roles within the medical device industry</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif\">Strong working knowledge of ISO 13485 and FDA Quality System Regulation</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif\">Demonstrated experience leading audits and managing regulatory inspections</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif\">Proven ability to manage and improve a QMS in a hands on environment</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif\">Strong documentation, organizational, and communication skills</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif\">Able to work independently and exercise sound judgment in a regulated setting</span></li>\n</ul>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-weight: bold\">Strongest candidates will also have:</span></p>\n<ul>\n<li><span style=\"font-family: arial, helvetica, sans-serif\">Experience supporting dental or Class I/II medical devices</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif\">Familiarity with ISO 14971 (risk management)</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif\">Experience in a startup or growing organization</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif\">Exposure to advanced materials or precision manufacturing environments</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif\">Experience supporting regulatory submissions or international registrations</span></li>\n</ul>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 18pt\">What We Offer</span></p>\n<ul>\n<li><span style=\"font-family: arial, helvetica, sans-serif\">Competitive compensation package with full benefits and paid vacation</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif\">The chance to own and shape the quality function at a company with real momentum</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif\">Direct impact on products reaching market. Your work clears the path.</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif\">A fast moving, collaborative team that values results and initiative</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif\">On site role based out of our Cambridge, ON facility</span></li>\n</ul>\n<p><span style=\"font-family: arial, helvetica, sans-serif\">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.</span></p>",
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