Manager, Quality Compliance

h3Changing lives. Building Careers. /h3pJoining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes. /ppThe Quality Compliance Manager is responsible for overseeing all Quality Management System activities, including CAPA management, site quality metrics, document control, training programs, internal and external audits, quality plans, health hazard evaluation, complaint trend analysis and complaint handling, ensuring compliance with Quality, Environmental, Health Safety policies and procedures. /ph3RESPONSIBILITIES /h3h3Complaint Management /h3ulliLead and oversee the Medical Device Complaint Management process, including complaint evaluation, investigation, and assessment of returned product samples. /liliEnsure complaints are appropriately triaged, investigated, documented, and closed within established timelines. /liliDrive root cause investigations and risk assessments to identify systemic issues and ensure product quality and patient safety. /liliEnsure timely escalation and management of critical quality and safety-related issues. /liliOversee complaint laboratory activities, ensuring equipment is maintained, calibrated, qualified, and operated in compliance with applicable procedures. /liliDefine, monitor, and report complaint management KPIs, ensuring effective communication with key stakeholders. /li /ulh3Audit Management /h3ulliManage the Site Internal Audit Program and ensure its effective implementation. /liliDevelop and maintain the annual audit schedule in compliance with corporate and regulatory requirements. /liliAssign qualified auditors and ensure adequate audit coverage across all relevant processes. /liliMaintain compliance with applicable standards and regulations, including ISO 13485, FDA 21 CFR Part 820, EU MDR, and other relevant regulatory requirements. /liliEnsure auditor qualification, competency, and ongoing development. /liliMonitor audit findings, nonconformities, and continuous improvement opportunities, ensuring timely implementation and verification of corrective actions. /li /ulh3Quality Systems, Compliance Regulatory Support /h3ulliEnsure compliance with Quality, Environmental, Health Safety policies and procedures, ISO 13485 requirements, applicable pharmacopoeias, and regulatory standards. /liliSupport Management Reviews and contribute to the achievement of Quality Objectives. /liliLead and support regulatory, certification, customer, and internal audits and inspections. /liliContribute to the development, implementation, maintenance, and continuous improvement of quality procedures, work instructions, and policies. /liliCoordinate Health Impact Assessments in collaboration with Design Quality Assurance, Regulatory Affairs, Corporate Quality, and other cross-functional stakeholders. /li /ulh3Training Management /h3ulliManage and maintain the Learning Management System (LMS), including training assignments, records management, and data integrity. /liliEnsure training compliance and support employee qualification requirements across the site. /li /ulh3Document Control /h3ulliManage and maintain the site Document Control System within the PLM environment. /liliEnsure controlled documentation is reviewed, approved, distributed, and archived in accordance with established procedures. /liliSupport the implementation and continuous improvement of document control processes and systems. /li /ulh3CAPA Management /h3ulliOwn and oversee the site CAPA process, ensuring timely and effective execution of corrective and preventive actions. /liliEnsure CAPA activities comply with applicable regulations, quality standards, and internal procedures. /liliFacilitate CAPA Review Board meetings and drive accountability for CAPA completion. /liliMonitor, analyze, and communicate CAPA process performance metrics to management. /liliPromote the effectiveness and continuous improvement of the CAPA system. /li /ulh3Team Leadership Resource Management /h3ulliLead, coach, and develop a multidisciplinary team of Quality Engineers and Quality Technicians. /liliAllocate resources and manage priorities to support operational, compliance, and project objectives. /liliEstablish, monitor, and evaluate individual performance objectives aligned with company goals and organizational strategy. /liliFoster a culture of accountability, collaboration, engagement, and continuous improvement. /li /ulh3Continuous Improvement /h3ulliIdentify and drive quality system and process improvement initiatives to enhance compliance, efficiency, and effectiveness. /liliSupport site-level operational excellence initiatives and cross-functional projects. /liliPromote a proactive quality culture focused on compliance, risk management, and continual improvement. /li /ulh3QUALIFICATIONS /h3ulliMinimum of a Master's degree in a Life Sciences discipline. /liliStrong knowledge of medical device standards and regulations, including ISO 13485, 93/42/EEC, EU MDR, and 21 CFR Part 820, Canadian, Japanese, Australian, Brazilian regulations, etc. /liliMinimum of 10 years professional experience in medical device or pharmaceutical manufacturing environments. /liliStrong management and leadership skills, with experience supervising laboratory teams. /liliExcellent communication, organizational, negotiation, and interpersonal skills. /liliStrong analytical and problem-solving abilities. /liliFluent in English and French /liliAbility to collaborate effectively with all levels of management across multiple sites and functions. /li /ul #J-18808-Ljbffr