Work Flexibility: Hybrid
Position Overview
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.
Key Responsibilities
Leadership & 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.)
* Some travel may be required
Travel Percentage: 20%