What We Need: At PDC by Brady, our commitment to quality extends beyond our products to include every facet of our operations. The QMS Compliance Specialist plays a key role in ensuring that our quality systems and processes adhere to the highest standards, ensuring regulatory compliance and supporting the overall pursuit of excellence across the organization. This position involves collaboration with multiple departments, including Engineering, Manufacturing, Regulatory Affairs, and Marketing, to ensure continuous improvement and compliance with industry regulations. What You'll Be Doing: + Lead the development, implementation, and maintenance of quality systems, ensuring alignment with ISO 9001, ISO 13485, ISO 14971, and FDA regulations. + Take ownership of document control systems, including user account management, document workflow optimization, and auditing, while supporting system proficiency for platforms like Smartsheets, ETQ, and SAP. + Manage and update quality-related documentation such as Standard Operating Procedures (SOPs), Quality Manual, Quality Policies, and related procedures, ensuring compliance with applicable medical device regulations. + Support New Product Development (NPD) projects, ensuring regulatory research is conducted and all necessary documentation (product registrations, certifications, and reports) is completed in compliance with environmental and regulatory standards. + Manage FDA Recall and Medical Device Reporting (MDR) procedures, maintaining timely facility registrations and device listings. + Assist with regulatory compliance for medical devices, cosmetics, and chemicals, including customer compliance requests, UDI labeling, and regulatory submissions (e.g., 510(k) submissions, eSubmitter). + Oversee the maintenance of FDA facility registrations and the management of accounts in platforms like GS1 US, FURL, and Webtrader. + Work closely with subject matter experts across departments to define product and material specifications, aligning with quality objectives and ensuring compliance. + Actively participate in continuous improvement projects, identifying opportunities to streamline quality processes and enhance system efficiency. + Collaborate with teams across Engineering, Manufacturing, Regulatory Affairs, and Marketing to achieve shared quality goals and ensure the smooth launch of new products. + Analyze quality data to identify trends and areas for improvement, and proactively address critical business issues that impact profitability. + Use data-driven insights to inform and support the development of quality initiatives that align with the company’s objectives. + Support customer compliance requests for medical devices, cosmetics, and other products, including advising on ISO certifications and chemical compliance (e.g., CA Prop 65, EU REACH, and RoHS). + Ensure all regulatory platforms (e.g., GS1, FURL, eSubmitter) are up-to-date, ensuring smooth compliance operations. What You Will Need To Be Successful: + Associate's degree or higher in a relevant field; relevant certifications (e.g., RAC, ASQ) are a plus. + 3-5 years of experience in regulatory affairs, compliance, or quality in the medical device industry. + Experience working with cross-functional teams, project management, and communication. + Knowledge of FDA regulations (21 CFR Part 7, 11, 803, 820), ISO standards (13485, 14971, 9001), and regulatory platforms (GS1, FURL, eSubmitter). + Strong attention to detail, organization, and problem-solving skills. + Proficiency in quality management systems, including Smartsheets, ETQ, SAP, and Google Workspace. + Ability to manage multiple priorities and deadlines in a fast-paced environment. + Strong written and verbal communication skills. + Familiarity with trade compliance processes (ACE/AOC, USMCA) is a plus. + Experience driving change and process improvements. + Hands-on experience with ETQ system configuration and workflow automation in Smartsheets. + Ability to work independently while collaborating effectively with teams. + Capacity to navigate complex regulatory requirements and maintain compliance in a dynamic environment. + Other duties as assigned. About Us: Who we are:When hospitals, schools, hotels, and even music festivals need to identify the people coming through their doors, they rely on PDC's expertise and solutions. As part of Brady Corporation's global portfolio of brands, PDC is a leader in identification solutions serving healthcare, government, education, entertainment and hospitality. PDC's breadth of products, from patient identification to music festival wristbands, are an integral part of Brady's identification solutions. But PDC's products and solutions are just one element of the Brady story. From the depths of the ocean to outer space, from the factory floor to the delivery room - Brady is just about everywhere you look. Companies around the world trust us because of our deep expertise and knowledge across a wide range of industries and applications - powered by our world-class manufacturing capabilities. We have a diverse customer base in industries including electronics, telecommunications, manufacturing, electrical, construction, healthcare, aerospace and more. As of July 31, 2024, Brady employed approximately 5,700 people worldwide. Our fiscal 2024 sales were approximately $1.34 billion. Brady stock trades on the New York Stock Exchange under the symbol BRC. You can learn more about us at www.bradycorp.com. Why work at Brady:A career at Brady means working for a global company that has thrived for over 100 years, and whose innovative spirit drives our future growth. And as a member of the PDC team, you'll get to represent a company with unique brand recognition across several industries. Brady offers competitive pay and great benefits, supported by a culture that encourages collaboration and innovation. We strive to foster an inclusive workplace where diverse talent can learn, grow, and succeed. And with deeply rooted values, no matter where you work at Brady, you'll feel connected to the community through our charitable contributions and opportunities to give back. Our headquarters are in Milwaukee, Wisconsin, but we have more than 70 locations globally, giving our employees the opportunity to work with colleagues around the world. Our Benefits: + Comprehensive insurance coverage starting on your first day of employment, including medical, dental, and vision + Generous 401(k) with company match + Paid time off and holidays + Opportunity to participate in incentive programs for all full-time employees + Family planning benefits including paid parental leave, fertility coverage, adoption and surrogacy assistance + Education reimbursement opportunities + Scholarship program for children of Brady employees + A variety of Employee Resource Groups to provide you with unique networking, development, and volunteer opportunities + Employee Assistance Program and related wellness programs (mental and behavioral health, family counseling, financial management) + Dress-for-your-day dress code + Charitable contributions matched through Brady's Matching Gift program