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Position OverviewÌý

The Director of Quality Systems will lead the development, implementation, and continuous improvement of the Quality Management System (QMS) for a complex multi divisional GQO sites (Arroyo, Skawina, Suzhou and Tijuana), ensuring compliance with all applicable regulatory standards and internal quality policies for medical devices. This role requires a strategic leader who can drive quality initiatives across the organization, manage teams, and collaborate effectively with cross-functional departments, including Manufacturing, and Supply Chain, to maintain the highest levels of product quality and safety.Ìý

Key ResponsibilitiesÌý

Leadership & StrategyÌý

• Lead and manage the Quality Systems department, providing guidance and direction to a team of quality professionals.Ìý

• Develop and implement the long-term strategy for the company’s Quality Management System (QMS) in alignment with business goals.Ìý
• Develops comprehensive data analysis frameworks to guide strategic decisions and integrates data insights into organizational planning.

Quality Management System (QMS)Ìý

• Oversee the design, implementation, and maintenance of the QMS, including document control, Change Control, CAPA (Corrective and Preventive Action), non-conformance management, and external and internal audits.Ìý

• Ensure timely and accurate submission of required reports and documentation to regulatory agencies.Ìý

• Manage internal audits, external audits and inspections to ensure readiness for audits.Ìý

• Review and approve quality metrics, reports, and analysis to identify opportunities for improvement.Ìý

Regulatory Compliance & Risk ManagementÌý

• Stay current with changes in medical device regulations, including FDA, EU MDR, and international standards, and ensure the organization’s QMS is always in compliance.Ìý

• Ensure that quality and regulatory documentation (e.g., design history files, device master records) are maintained and accurate.Ìý

• Manage risk management processes in accordance with ISO 14971, including risk assessments and mitigation strategies for all medical device products.Ìý

Cross-functional Collaboration & TrainingÌý

• Collaborate closely with AO, Manufacturing, and Supply Chain teams to ensure quality and compliance are built into product development and production processes.Ìý

• Provide training and mentorship to employees across the franchise to ensure understanding of QMS requirements and best practices.Ìý

• Develop and deliver regular quality system reviews and training sessions to senior leadership and other stakeholders.Ìý

Continuous Improvement & Problem SolvingÌý

• Champion continuous improvement initiatives across the organization to enhance product quality and compliance
• Lead root cause analysis and corrective actions to resolve quality issues and prevent recurrence.Ìý

• Identify and implement process improvements to enhance efficiency, reduce costs, and improve product quality.Ìý

• Utilize Six Sigma, Lean, or other methodologies to drive process optimization and quality performance.Ìý

Reporting & DocumentationÌý

• Provide regular updates to senior leadership on quality performance, risks, and improvement initiatives.Ìý

• Manage the preparation of regulatory submissions and audits, ensuring all required documents are completed and submitted on time.Ìý

• Oversee the preparation of quality system documentation for internal and external reviews.Ìý

Qualifications:

• Bachelor’s Degree â€� United States of America & IrelandÌý

• EQF Level 6 or equivalentÌý â€� EUÌý

• Masters / PhD advantageous (EQF Level 7 or 8 advantageous)Ìý

Qualifications & Experience:Ìý

• Minimum of 15+ yearsâ€� experience in a Medical, Pharmaceutical, Bio-Medical/Pharma, Automotive or regulated manufacturing environmentÌý

• Minimum of 8 yearsâ€� experience and a proven track record of successfully creating and managing highly talented, engaged and performing teams preferred with Multi Site responsibilityÌý

• Profound knowledge and understanding of US, European and International Medical Device Regulations (ISO 13485, MDSAP, and CFR Part 820 Quality System Regulations desired)Ìý

• Profound knowledge of supporting Quality Systems (e.g. Audits, Management review, Quality Planning).Ìý Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.Ìý

• Demonstrated leadership ability to influence, develop and implement organisation and functional strategy.Ìý Influences, initiates, sponsors and implements change with a demonstrated track record.Ìý

• Develops strategic partnerships, innovates and optimizes problem-solving methodologies, champions a culture of continuous improvement, leads enterprise-wide data strategy, and fosters a culture of continuous learning.Ìý

• Capable of overseeing large-scale projects with minimal supervision, fosters a motivated organizational culture, aligns strategic priorities with long-term goals, and creates comprehensive demand management frameworks.Ìý

• Crafts strategic communication frameworks for executives, cultivates an open communication culture, and integrates communication strategies to align organizational goals.Ìý

• Demonstrated ability to lead virtual teams to high performance and integrates cross-functional efforts to drive strategic initiatives.Ìý Must be able to work in a team & individual environments, interacting effectively at all levels, and across all functions with ability to develop organisational relationship and build trust.Ìý

• High level of PC skills required. Ì�

• Fluent in written and oral English - B2 Level (writing documents, meeting minutes, conference calls, etc.)Ìý
• Some travel may be requiredÌý