Work Flexibility: HybridPosition OverviewThe 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.Key ResponsibilitiesLeadership & Strategy
Lead and manage the Quality Systems department, providing guidance and direction to a team of quality professionals.
Develop and implement the long-term strategy for the company’s Quality Management System (QMS) in alignment with business goals.
Develops comprehensive data analysis frameworks to guide strategic decisions and integrates data insights into organizational planning.
Quality Management System (QMS)
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.
Ensure timely and accurate submission of required reports and documentation to regulatory agencies.
Manage internal audits, external audits and inspections to ensure readiness for audits.
Review and approve quality metrics, reports, and analysis to identify opportunities for improvement.
Regulatory Compliance & Risk Management
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.
Ensure that quality and regulatory documentation (e.g., design history files, device master records) are maintained and accurate.
Manage risk management processes in accordance with ISO 14971, including risk assessments and mitigation strategies for all medical device products.
Cross-functional Collaboration & Training
Collaborate closely with AO, Manufacturing, and Supply Chain teams to ensure quality and compliance are built into product development and production processes.
Provide training and mentorship to employees across the franchise to ensure understanding of QMS requirements and best practices.
Develop and deliver regular quality system reviews and training sessions to senior leadership and other stakeholders.
Continuous Improvement & Problem Solving
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.
Identify and implement process improvements to enhance efficiency, reduce costs, and improve product quality.
Utilize Six Sigma, Lean, or other methodologies to drive process optimization and quality performance.
Reporting & Documentation
Provide regular updates to senior leadership on quality performance, risks, and improvement initiatives.
Manage the preparation of regulatory submissions and audits, ensuring all required documents are completed and submitted on time.
Oversee the preparation of quality system documentation for internal and external reviews.
Qualifications:
Bachelor’s Degree – United States of America & Ireland
EQF Level 6 or equivalent – EU
Masters / PhD advantageous (EQF Level 7 or 8 advantageous)
Qualifications & Experience:
Minimum of 15+ years’ experience in a Medical, Pharmaceutical, Bio-Medical/Pharma, Automotive or regulated manufacturing environment
Minimum of 8 years’ experience and a proven track record of successfully creating and managing highly talented, engaged and performing teams preferred with Multi Site responsibility
Profound knowledge and understanding of US, European and International Medical Device Regulations (ISO 13485, MDSAP, and CFR Part 820 Quality System Regulations desired)
Profound knowledge of supporting Quality Systems (e.g. Audits, Management review, Quality Planning). Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.
Demonstrated leadership ability to influence, develop and implement organisation and functional strategy. Influences, initiates, sponsors and implements change with a demonstrated track record.
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.
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.
Crafts strategic communication frameworks for executives, cultivates an open communication culture, and integrates communication strategies to align organizational goals.
Demonstrated ability to lead virtual teams to high performance and integrates cross-functional efforts to drive strategic initiatives. 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.
High level of PC skills required.
Fluent in written and oral English - B2 Level (writing documents, meeting minutes, conference calls, etc.)
