Direct Of Quality

Overview: We are seeking an experienced and visionary Director of Quality to lead our organizations quality assurance and quality control efforts. The Director of Quality will be responsible for developing and executing a comprehensive quality strategy driving continuous improvement initiatives and ensuring adherence to regulatory requirements and industry standards. The ideal candidate will have a proven track record of leading crossfunctional teams implementing quality management systems and driving a culture of quality excellence.

Responsibilities:

1. Develop and implement a strategic vision for quality management that aligns with the organizations goals and objectives.
2. Establish and maintain a robust quality management system that encompasses quality assurance quality control and continuous improvement processes.
3. Lead and mentor a team of quality professionals providing guidance coaching and support to drive performance excellence.
4. Define key performance indicators (KPIs) and metrics to monitor and evaluate quality performance across the organization.
5. Collaborate with crossfunctional teams to identify and implement best practices for quality assurance and control throughout the product lifecycle.
6. Drive a culture of quality excellence by promoting awareness accountability and ownership of quality throughout the organization.
7. Ensure compliance with regulatory requirements industry standards and customer specifications including FDA regulations ISO standards and other relevant quality standards.
8. Lead audits and inspections by regulatory agencies customers and thirdparty organizations and drive corrective and preventive actions as necessary.
9. Partner with suppliers and vendors to establish quality standards and requirements for incoming materials and components.
10. Oversee the investigation and resolution of product quality issues customer complaints and nonconformances ensuring root cause analysis and corrective actions are implemented effectively.
11. Develop and deliver qualityrelated training programs to enhance the capabilities of employees across the organization.
12. Stay abreast of emerging trends technologies and regulations in quality management and recommend appropriate actions to maintain a competitive advantage.

Qualifications:

1. Bachelors degree in engineering quality management or a related field; advanced degree preferred.
2. Minimum of 35 years of progressive experience in quality management roles with a track record of increasing responsibility and leadership.
3. Strong understanding of quality management principles methodologies and tools such as Six Sigma Lean and Total Quality Management.
4. Proven experience developing and implementing quality management systems such as ISO 9001 ISO 13485 or similar standards.
5. Excellent leadership strategic planning and interpersonal skills with the ability to influence and inspire teams at all levels of the organization.
6. Strong analytical and problemsolving abilities with a focus on datadriven decisionmaking.
7. Experience leading quality initiatives in regulated industries such as healthcare pharmaceuticals or medical devices is preferred.
8. Certification in quality management (e.g. Certified Quality Manager Six Sigma Master Black Belt) is a plus.

Remote Work :

No