Quality Leadership & GovernanceProvide strategic leadership for Quality Assurance activities across multiple Medical Device Services sites.Develop, implement, and maintain a harmonized Quality Management System (QMS) aligned with corporate and regulatory requirements.Establish quality objectives, key performance indicators (KPIs), and continuous improvement initiatives across all sites.Foster a culture of quality, compliance, accountability, and customer focus.Lead Management Review processes and communicate quality performance metrics to executive leadership.Ensure effective escalation and resolution of significant quality and compliance issues.  Regulatory & Quality ComplianceEnsure compliance with applicable regulatory, accreditation, and quality standards, including:ISO/IEC 17025OECD Good Laboratory Practice (GLP) and FDA 21 CFR Part 58FDA 21 CFR Part 11FDA Quality Management System Regulation (QMSR) / 21 CFR Part 820, as applicableISO 13485, as applicableMedical Device Single Audit Program (MDSAP), where applicableEuropean Union Medical Device Regulation (EU MDR), where applicableOther applicable national and international regulatory and accreditation requirementsLead Quality Systems supporting ISO/IEC 17025-accredited laboratories and GLP-compliant operations while ensuring appropriate application of QMSR and ISO 13485 requirements where applicable.
Monitor changes in regulatory, accreditation, and industry standards and ensure timely implementation across all Medical Device Services sites.
Serve as the executive Quality representative during regulatory inspections, accreditation assessments, customer audits, and corporate Quality reviews.
Ensure timely and sustainable resolution of compliance observations, audit findings, and regulatory commitments through effective corrective and preventive action.Quality Systems OversightProvide oversight and approval for Quality Systems elements such as:Deviations and quality eventsCAPA investigationsChange controlsRisk assessmentsInternal auditsSupplier qualification and monitoring programsTraining and qualification systemsDocument control processesEnsure effectiveness of quality systems through trending, monitoring, and management review activities.Drive standardization and harmonization of procedures across all sites.Audit & Inspection ManagementLead preparation and execution of:FDA inspectionsISO and accreditation auditsCustomer auditsCorporate quality auditsEnsure audit readiness across all locations.Oversee responses to observations and ensure sustainable corrective actions are implemented.Monitor inspection trends and proactively address systemic quality risks.Continuous Improvement & Operational ExcellenceChampion continuous improvement initiatives utilizing Lean, Six Sigma, risk-based quality management, and operational excellence principles.Drive quality metric reviews and identify opportunities for process optimization.Promote data-driven decision making and quality risk management practices.Support business expansion, new service offerings, and site integration activities from a quality perspective.Leadership & People ManagementLead and develop site QA Managers, Supervisors, and quality professionals.Establish talent development, succession planning, and performance management processes.Ensure appropriate staffing levels and resource allocation across sites.Mentor quality leaders and support employee engagement initiatives.Promote collaboration among Quality, Operations, Regulatory Affairs, Technical, and Client Services teams.Technical Knowledge RequirementsStrong working knowledge of:FDA 21 CFR Part 820FDA 21 CFR Part 11ISO 13485ISO 17025Medical Device Single Audit Program (MDSAP)Risk Management principles (ISO 14971 preferred)CAPA systemsChange Control systemsInternal Audit programsSupplier Quality ManagementData Integrity requirementsValidation and Computer System Validation conceptsStatistical and trend analysis methodologiesElectronic Quality Management Systems (eQMS)
