Senior Manager Quality Systems

Responsibilitiesarrow_right * Lead the development, deployment, and continuous improvement of a harmonized global QMS aligned with internal policies, ISO 13485, FDA (21 CFR 820/QMSR), EU MDR, and other applicable regulations. * Establish standard work, governance, and KPIs to ensure consistent audit execution and audit readiness across all sites. * Act as global process owner for key quality system elements, including internal audits, external audits, CAPA effectiveness, and risk management. * Develop and execute a global, internal audit program across all manufacturing sites and functions. * Ensure readiness for regulatory, customer, and notified body audits; provide leadership during inspections (front room/back room support). * Identify systemic gaps and drive timely, effective remediation and CAPA closure. * Develop and implement compliance risk assessment model identifying and prioritizing high risk areas. * Partner with site Quality, Operations, and Engineering teams to improve product quality and Quality System effectiveness through a robust CAPA process. * Lead and coach complex investigations into product failures, complaints, and quality signals using structured root cause methodologies. * Drive global alignment on root cause analysis (RCA) standards, tools, and training. * Ensure effective integration of risk management activities (e.g., FMEA, hazard analysis) into product and process improvements. * Partner with Quality leaders across regions and sites to ensure consistent interpretation and application of Corporate QMS requirements. * Support site leadership in regulatory interactions and compliance strategies. * Influence cross-functional stakeholders to enable risk-based decision making and a proactive quality culture. * Build and sustain a culture of compliance, accountability, and continuous improvement. * Lead training initiatives to strengthen audit readiness, RCA capability, and quality system effectiveness. * Mentor and develop Quality leaders and key talent across the organization. Qualificationsarrow_right * University degree in Engineering, Life Sciences, or related field. * 10+ years of progressive experience in Quality and/or Regulatory Affairs within the medical device industry. * Proven experience in medical device, component manufacturing in multi-site or global manufacturing environments. * Demonstrated leadership in developing and maintaining ISO 13485, MDSAP, FDA (21 CFR 820/QMSR), EU MDR, ISO 14971, and FDA-compliant Quality Management systems. * Solid understanding of process validation, design and development, and risk management activities as they relate to medical devices and components for medical devices. * Effective communicator with strong strategic, analytical, and leadership skills. * Ability to balance strategic leadership with operational execution. * Demonstrated experience leading global audit programs and regulatory inspections. * Proven track record in root cause analysis, CAPA, and product quality improvement. * Experience managing and developing teams in a global, matrixed organization. * Business leadership role requires domestic and international travel (up to 40%).