Direct Of Quality
3 weeks ago
Responsibilities:
Develop and implement a strategic vision for quality management that aligns with the organization's goals and objectives.
Establish and maintain a robust quality management system that encompasses quality assurance, quality control, and continuous improvement processes.
Lead and mentor a team of quality professionals, providing guidance, coaching, and support to drive performance excellence.
Define key performance indicators (KPIs) and metrics to monitor and evaluate quality performance across the organization.
Collaborate with cross-functional teams to identify and implement best practices for quality assurance and control throughout the product lifecycle.
Drive a culture of quality excellence by promoting awareness, accountability, and ownership of quality throughout the organization.
Ensure compliance with regulatory requirements, industry standards, and customer specifications, including FDA regulations, ISO standards, and other relevant quality standards.
Lead audits and inspections by regulatory agencies, customers, and third-party organizations, and drive corrective and preventive actions as necessary.
Partner with suppliers and vendors to establish quality standards and requirements for incoming materials and components.
Oversee the investigation and resolution of product quality issues, customer complaints, and non-conformances, ensuring root cause analysis and corrective actions are implemented effectively.
Develop and deliver quality-related training programs to enhance the capabilities of employees across the organization.
Stay abreast of emerging trends, technologies, and regulations in quality management and recommend appropriate actions to maintain a competitive advantage.
Qualifications:
Bachelor's degree in engineering, quality management, or a related field; advanced degree preferred.
Minimum of 3-5 years of progressive experience in quality management roles, with a track record of increasing responsibility and leadership.
Strong understanding of quality management principles, methodologies, and tools, such as Six Sigma, Lean, and Total Quality Management.
Proven experience developing and implementing quality management systems, such as ISO 9001, ISO 13485, or similar standards.
Excellent leadership, strategic planning, and interpersonal skills, with the ability to influence and inspire teams at all levels of the organization.
Strong analytical and problem-solving abilities, with a focus on data-driven decision-making.
Experience leading quality initiatives in regulated industries, such as healthcare, pharmaceuticals, or medical devices, is preferred.
Certification in quality management (e.g., Certified Quality Manager, Six Sigma Master Black Belt) is a plus.
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