Manager, Quality Compliance

ppChanging lives. Building Careers. /p pJoining 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. /p pThe 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. /p h3Complaint Management /h3 ul liLead and oversee the Medical Device Complaint Management process, including complaint evaluation, investigation, and assessment of returned product samples. /li liEnsure complaints are appropriately triaged, investigated, documented, and closed within established timelines. /li liDrive root cause investigations and risk assessments to identify systemic issues and ensure product quality and patient safety. /li liEnsure timely escalation and management of critical quality and safety‑related issues. /li liOversee complaint laboratory activities, ensuring equipment is maintained, calibrated, qualified, and operated in compliance with applicable procedures. /li liDefine, monitor, and report complaint management KPIs, ensuring effective communication with key stakeholders. /li /ul h3Audit Management /h3 ul liManage the Site Internal Audit Program and ensure its effective implementation. /li liDevelop and maintain the annual audit schedule in compliance with corporate and regulatory requirements. /li liAssign qualified auditors and ensure adequate audit coverage across all relevant processes. /li liMaintain compliance with applicable standards and regulations, including ISO 13485, FDA 21 CFR Part 820, EU MDR, and other relevant regulatory requirements. /li liEnsure auditor qualification, competency, and ongoing development. /li liMonitor audit findings, nonconformities, and continuous improvement opportunities, ensuring timely implementation and verification of corrective actions. /li /ul h3Quality Systems, Compliance Regulatory Support /h3 ul liEnsure compliance with Quality, Environmental, Health Safety policies and procedures, ISO 13485 requirements, applicable pharmacopoeias, and regulatory standards. /li liSupport Management Reviews and contribute to the achievement of Quality Objectives. /li liLead and support regulatory, certification, customer, and internal audits and inspections. /li liContribute to the development, implementation, maintenance, and continuous improvement of quality procedures, work instructions, and policies. /li liCoordinate Health Impact Assessments in collaboration with Design Quality Assurance, Regulatory Affairs, Corporate Quality, and other cross‑functional stakeholders. /li /ul h3Training Management /h3 ul liManage and maintain the Learning Management System (LMS), including training assignments, records management, and data integrity. /li liEnsure training compliance and support employee qualification requirements across the site. /li /ul h3Document Control /h3 ul liManage and maintain the site Document Control System within the PLM environment. /li liEnsure controlled documentation is reviewed, approved, distributed, and archived in accordance with established procedures. /li liSupport the implementation and continuous improvement of document control processes and systems. /li /ul h3CAPA Management /h3 ul liOwn and oversee the site CAPA process, ensuring timely and effective execution of corrective and preventive actions. /li liEnsure CAPA activities comply with applicable regulations, quality standards, and internal procedures. /li liFacilitate CAPA Review Board meetings and drive accountability for CAPA completion. /li liMonitor, analyze, and communicate CAPA process performance metrics to management. /li liPromote the effectiveness and continuous improvement of the CAPA system. /li /ul h3Team Leadership Resource Management /h3 ul liLead, coach, and develop a multidisciplinary team of Quality Engineers and Quality Technicians. /li liAllocate resources and manage priorities to support operational, compliance, and project objectives. /li liEstablish, monitor, and evaluate individual performance objectives aligned with company goals and organizational strategy. /li liFoster a culture of accountability, collaboration, engagement, and continuous improvement. /li /ul h3Continuous Improvement /h3 ul liIdentify and drive quality system and process improvement initiatives to enhance compliance, efficiency, and effectiveness. /li liSupport site-level operational excellence initiatives and cross‑functional projects. /li liPromote a proactive quality culture focused on compliance, risk management, and continual improvement. /li /ul h3Qualifications /h3 ul liMinimum of a Master’s degree in a Life Sciences discipline. /li liStrong 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. /li liMinimum of 10 years professional experience in medical device or pharmaceutical manufacturing environments. /li liStrong management and leadership skills, with experience supervising laboratory teams. /li liExcellent communication, organizational, negotiation, and interpersonal skills. /li liStrong analytical and problem‑solving abilities. /li liFluent in English and French /li liAbility to collaborate effectively with all levels of management across multiple sites and functions. /li /ul /p #J-18808-Ljbffr